Best Practices for 
Communication Between 
IND Sponsors and FDA 
During Drug Development 
Guidance for Industry and  
Review Staff 
 
Good Review Practice 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
December 2017 
Procedural 
   
Best Practices for 
Communication Between 
IND Sponsors and FDA 
During Drug Development 
Guidance for Industry and  
Review Staff 
 
Good Review Practice 
 
Additional copies are available from: 
 
Office of Communications, Division of Drug Information 
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD  20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: druginfo@fda.hhs.gov 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
 
and/or 
 
Office of Communication, Outreach, and Development  
Center for Biologics Evaluation and Research 
Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, rm. 3128 
Silver Spring, MD  20993-0002 
Phone: 800-835-4709 or 240-402-8010; Email: ocod@fda.hhs.gov 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
December 2017 
Procedural 
   
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  FDAS PHILOSOPHY REGARDING COMMUNICATION WITH SPONSORS ... 3 
IV.  SCOPE OF INTERACTIONS BETWEEN THE SPONSOR AND THE REVIEW 
TEAM................................................................................................................................. 5 
V.  TYPES OF ADVICE THAT ARE APPROPRIATE FOR SPONSORS TO SEEK ... 8 
VI.  GENERAL EXPECTATIONS FOR TIMING OF COMMUNICATIONS................ 9 
VII.  BEST PRACTICES AND COMMUNICATION METHODS ................................... 12 
A.  Formal Meetings Between FDA and Sponsors .......................................................................... 13 
B.  Written Correspondence From FDA ......................................................................................... 18 
C.  Submissions From Sponsors ....................................................................................................... 18 
D.  Acknowledging Receipt of Communications ............................................................................. 20 
E.  Email Between FDA and Sponsors ............................................................................................. 20 
F.  General Telephone Calls Between FDA and Sponsors ............................................................. 20 
G.  Faxes Between FDA and Sponsors ............................................................................................. 21 
H.  Use of Out-of-Office Messages by FDA and Sponsors .............................................................. 21 
I.  Resources for Sponsors ................................................................................................................ 21 
1. FDA Guidances .............................................................................................................................. 21 
2. FDA Policy and Procedures .......................................................................................................... 22 
3. FDA Basics for Industry ................................................................................................................ 22 
4. FDA Interactive Media .................................................................................................................. 22 
5. FDA Presentations ......................................................................................................................... 23 
6. FDA Labeling and Approvals ........................................................................................................ 23 
7. FDA Rules and Regulations ........................................................................................................... 24 
8. FDA-Funded Scientific Research Results ...................................................................................... 24 
9. Code of Federal Regulations ......................................................................................................... 24 
VIII.  ADDITIONAL CONTACTS ......................................................................................... 24 
A.  CDER ............................................................................................................................................ 25 
1. Biomarker Qualification Program ................................................................................................. 25 
2. Controlled Substance Staff ............................................................................................................. 26 
3. Division of Drug Information ........................................................................................................ 26 
4. Division of Pediatric and Maternal Health ................................................................................... 26 
5. Emerging Technology Team .......................................................................................................... 26 
6. Enhanced Communication Team ................................................................................................... 27 
7. Import/Export ................................................................................................................................. 27 
8. Office of Pharmaceutical Quality .................................................................................................. 27 
9. Ombudsman ................................................................................................................................... 28 
10.  Rare Diseases Program ............................................................................................................. 28 
11.  Small Business and Industry Assistance Program .................................................................... 28 
i 
   
12.  Therapeutic Biologics and Biosimilars Staff ............................................................................. 29 
B.  CBER ............................................................................................................................................ 29 
1. Manufacturers Assistance and Technical Training Branch........................................................... 29 
2. Ombudsman ................................................................................................................................... 29 
C.  Office of Special Medical Programs ........................................................................................... 30 
1. Advisory Committee Oversight and Management Staff ................................................................. 30 
2. Office of Combination Products .................................................................................................... 30 
3. Office of Good Clinical Practice ................................................................................................... 31 
4. Office of Orphan Products Development ....................................................................................... 31 
5. Office of Pediatric Therapeutics .................................................................................................... 32 
REFERENCES ............................................................................................................................ 33 
 
ii 
  Contains Nonbinding Recommendations 
Best Practices for Communication Between  
IND Sponsors and FDA During Drug Development 
Guidance for Industry and Review Staff1
 
 
Good Review Practice 
 
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the 
title page.   
 
 
 
 
I.  INTRODUCTION  
 
The purpose of this guidance is to describe best practices and procedures for timely, transparent, 
and effective communications between investigational new drug application (IND) sponsors2 and 
FDA at critical junctures in drug3 development, which may facilitate earlier availability of safe 
and effective drugs to the American public.  This guidance applies to communications between 
IND sponsors and FDA during the IND phase of drug development, including biosimilar 
biological product development (BPD).  This guidance describes: 
 
  FDAs philosophy regarding timely interactive communication with IND sponsors as a 
core activity  
 
  The scope of appropriate interactions between review teams and IND sponsors  
 
  The types of advice appropriate for IND sponsors to seek from FDA in pursuing their 
drug development programs  
 
  General expectations for the timing of FDA response to IND sponsor inquiries  
 
                                                 
1 This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) in cooperation with the 
Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. 
 
2 For the purposes of this guidance, all references to sponsors include both sponsors and their authorized officials as 
described in 21 CFR 312.3 and 312.23(a)(1)(ix). 
 
3 For the purposes of this guidance, all references to drugs or drug products include human drug products, including 
biological drug products, regulated by CDER and CBER, unless otherwise specified. 
1  Contains Nonbinding Recommendations 
  Best practices and communication methods to facilitate interactions between review 
teams and IND sponsors during drug development  
 
  Expectations for appropriate methods, including the frequency, of such communications   
 
This guidance does not apply to communications or inquiries from industry trade organizations, 
consumer or patient advocacy organizations, other government agencies, or other stakeholders 
not pursuing a development program under an IND. 
 
Although this guidance describes FDAs current best communication practices, it should be 
appreciated that with additional feedback from sponsors and review staff processes may evolve 
further.  As additional best practices are identified or established, this guidance may be updated. 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.  Although guidance documents do not legally bind FDA, review staff may depart 
from guidance documents only with appropriate justification and supervisory concurrence. 
 
 
II.  BACKGROUND 
 
On July 9, 2012, the President signed the Food and Drug Administration Safety and Innovation 
Act, which includes the Prescription Drug User Fee Amendments of 2012 (PDUFA V).  As 
directed by Congress in the Food and Drug Administration Amendments Act of 2007, FDA 
developed the proposed enhancements for PDUFA V in consultation with drug industry 
representatives, patient and consumer advocates, health care professionals, and other public 
stakeholders.  These goals are described in PDUFA Reauthorization Performance Goals and 
Procedures Fiscal Years 2013 through 2017.4  Under the PDUFA V goals, FDA agreed to 
develop a dedicated drug development communication and training staff within the Center for 
Drug Evaluation and Research (CDER) and augment the Manufacturers Assistance and 
Technical Training Branch (MATTB) staff in the Center for Biologics Evaluation and Research 
(CBER) to focus on enhancing communication between sponsors and FDA during drug 
development.  
 
CDER and CBER agreed to publish this joint guidance for industry and review staff on best 
practices for communication between sponsors and FDA during drug development.  CDER and 
CBER gathered review staff best practices and incorporated input from interested parties to 
inform the content of this guidance. 
 
The IND phase of drug development is the time during which human trials of investigational 
drugs are conducted.  From FDAs perspective, the IND phase of drug development spans the 
time from the first IND-related submission (including a pre-IND or Biosimilar Initial Advisory 
(BIA) meeting request or an original IND) to the submission of a marketing application.  The 
                                                 
4 https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf 
2  Contains Nonbinding Recommendations 
IND phase may also extend beyond initial approval or licensure to include additional trials 
relevant to the drugs development and labeling.  From the sponsors perspective, drug 
development is not limited to the IND phase because it also includes drug discovery and early 
development of compounds before IND submission and may include clinical trials conducted in 
other countries outside a U.S. IND.5 
 
Each year, sponsors and FDA engage in thousands of communications, including meetings and 
teleconferences, during the IND phase of drug development.  Because these communications are 
often opportunities to share information and provide critical advice (e.g., trial design, dose 
selection, analytical similarity assessment, nonclinical study requirements, manufacturing and 
facility issues), it is important that interactions be conducted efficiently and consistently, with 
clear, concise, and timely communication.   
 
 
III.  FDAS PHILOSOPHY REGARDING COMMUNICATION WITH SPONSORS 
 
Ideally, sponsors and FDA work collaboratively during the drug development process, having a 
shared public health goal of early availability of safe, effective, and high-quality drugs to the 
American public.  In this process, sponsors and FDA have distinct roles and primary areas of 
responsibility. 
 
  Sponsors primary responsibilities are managing the overall development of their drugs 
(e.g., supporting well-designed and well-conducted nonclinical and clinical trials for 
approval while ensuring patient safety and drug quality), determining the nature and 
timing of regulatory submissions to their INDs, soliciting input and guidance from FDA 
during the course of their development programs, and providing well-organized and 
complete IND submissions (including amendments and supplementary information) to 
FDA for review.  
 
  FDAs primary responsibilities with respect to INDs are, during all phases of 
investigation, to ensure the safety and rights of subjects, and, during phase 2 and phase 3, 
to help ensure that the quality of the scientific evaluation of a drug is adequate to permit 
the evaluation of the drugs effectiveness and safety.6 FDA also has the important 
responsibility of enforcing requirements related to good clinical practice (GCP) and 
human subject protections (HSP).  FDA reviews IND submissions and takes regulatory 
actions (e.g., clinical hold) as appropriate.  FDA review staff also play active roles during 
drug development by providing advice and feedback to sponsors on specific trials and 
overall development programs based on their review of IND submissions and in meetings 
conducted between sponsors and FDA.  Finally, FDA promotes the advancement of 
regulatory science by authoring FDA and international guidances, conducting and 
                                                 
5 For more information on the use of information relating to foreign clinical trials in INDs and applications for 
marketing approval submitted to FDA, see the guidance for industry and FDA staff FDA Acceptance of Foreign 
Clinical Studies Not Conducted Under an IND:  Frequently Asked Questions.  We update guidances periodically.  
To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
 
6 21 CFR 312.22 
3  Contains Nonbinding Recommendations 
participating in public workshops and public or private consortia, collaborating with 
academia, publishing in medical and trade journals, and presenting scientific and 
regulatory topics at professional conferences.  
 
FDA believes that the timely review of IND submissions with appropriate feedback to sponsors 
can result in greater efficiency of the drug development process.  At the sponsors request, FDA 
will, if possible, provide advice on specific matters relating to an IND.  Examples include 
providing advice on the adequacy of technical data to support an investigational plan, the design 
of a clinical trial, and whether proposed investigations are likely to produce the data and 
information needed to meet requirements for a marketing application.7  Because the complexity 
and importance of material submitted to an IND will vary by therapeutic indication and drug 
development stage, the review divisions retain the flexibility to determine the extent of review 
and feedback provided for each submission.  For drugs developed under expedited programs, 
such as breakthrough therapy and fast track, sponsors receive more intensive guidance on an 
efficient drug development program with increased interactions and communications with FDA, 
including meetings.8 
 
FDA believes that scientific and regulatory recommendations provided during drug development 
meetings with sponsors may result in more efficient and robust development programs.  This 
philosophy is articulated in 21 CFR 312.47, 21 CFR 312.82, FDAs meetings guidances,9 
CDERs Manuals of Policies and Procedures (MAPPs), and CBERs Standard Operating Policy 
and Procedures (SOPPs).  Sponsors can request meetings with FDA at any time during drug 
development, and FDA strongly encourages sponsors to request the critical milestone meetings, 
and BIA or BPD meetings identified in the references cited above.  FDAs decision to grant or 
deny meeting requests is resource-dependent and is based on the maturity of the drugs 
development at the time of the meeting request, taking into consideration the potential utility of 
the meeting.  The procedures for requesting and conducting effective meetings between sponsors 
and FDA are fully described in the meetings guidances.  
 
Timelines established by statute and/or regulation apply to the review of certain submission 
types (e.g., initial IND submissions) and CDER and CBER strive to review and provide timely 
feedback for other types of submissions that lack such required review timelines (e.g., a new 
phase 2 protocol under an active IND or a new clinical study protocol for products in the BPD 
program), as resources allow.  CDER has documented its good review practices and principles 
                                                 
7 21 CFR 312.41(b) 
 
8 See CDER MAPP 6025.6 Good Review Practice:  Management of Breakthrough Therapy-Designated Drugs and 
Biologics 
(https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesPro
cedures/default.htm) and CBER SOPP 8212 Management of Breakthrough Therapy-Designated Products: Sponsor 
Interactions and Status Assessment Including Rescinding 
(https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/ucm
506010.htm). 
 
9 See the guidances for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA 
Products and Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.   
 
4  Contains Nonbinding Recommendations 
during the IND phase of drug development in a MAPP.10  Incorporation of the principles 
outlined in the MAPP into IND review processes is resource-dependent and intended to improve 
safety oversight and facilitate effective communication between sponsors and FDA during drug 
development.  The MAPP lists timelines for the review of and response to certain IND 
submissions, including recommended timelines where there is no required timeline (e.g., some 
safety-related submissions, drug development submissions without regulatory timelines where 
communication to the sponsor is often critical and recommended, and other submissions where 
communication with the sponsor may be needed).  Although FDA review staff continually strive 
to meet the recommended review timelines for IND submissions described in the MAPP, they 
must balance this work with other critical public health responsibilities, including new drug 
application/biologics license application (NDA/BLA) review and oversight of drug safety.  
 
FDA may at any time during the course of an IND communicate with the sponsor orally or in 
writing about deficiencies in the IND or about FDAs need for more data or information.  Unless 
the communication is accompanied by a clinical hold order under 21 CFR 312.42, FDA 
communications with a sponsor under 21 CFR 312.41 are solely advisory and do not require any 
modification in the planned or ongoing clinical investigations or response to FDA.11   
 
 
IV.  SCOPE OF INTERACTIONS BETWEEN THE SPONSOR AND THE REVIEW 
TEAM 
 
Regulatory project managers (RPMs) oversee projects, processes, and programs.  RPMs in 
CDER review divisions or CBER review offices are commonly referred to as review division 
RPMs.  Other RPMs that operate in specific functional areas of FDA are sometimes referred to 
as process managers or program managers.  Collectively, the review division RPMs and specific 
functional area RPMs are referred to as FDA RPMs.   
 
FDA RPMs communicate on FDAs behalf via written correspondence, email, fax, or telephone.  
FDA RPMs are also the primary contacts for facilitating the timely resolution of technical, 
scientific, and regulatory questions, conflicts, or communication challenges between sponsors 
and the review teams.  
 
The review division RPM is the primary point of contact for communications between a sponsor 
and FDA during the life cycle of drug development.  As a co-leader of the FDA review team, the 
review division RPM has comprehensive knowledge of the drug and its regulatory history. 
 
However, there are limited circumstances during drug development when it is appropriate for 
sponsors to directly contact FDA RPMs other than the review division RPMs, such as 
contacting: 
 
                                                 
10 See CDER MAPP 6030.9 Good Review Practice:  Good Review Management Principles and Practices for 
Effective IND Development and Review. 
 
11 21 CFR 312.41(c) 
5  Contains Nonbinding Recommendations 
  CDERs Office of Pharmaceutical Quality (OPQ) regulatory business process managers 
(RBPMs).  They manage meeting requests, regulatory submissions, and other inquiries 
that are solely related to chemistry, manufacturing, and controls, including facility and 
product quality issues. 
 
  CDERs Office of Surveillance and Epidemiology safety RPMs.  They manage 
regulatory submissions and other inquiries related to proprietary names, biosimilar 
suffixes, human factors, and Sentinel/Active Risk Identification and Analysis 
assessments.  
 
  CDERs Formal Dispute Resolution Project Manager.  This person manages sponsor 
requests for resolving scientific and/or medical disputes that cannot be resolved at the 
division level.12  
 
There are also limited circumstances when sponsors may use certain FDA points of contact for 
responses to basic or procedural drug development questions not directly linked to an existing or 
planned development program.  These contacts may be in specific functional areas and serve as 
an alternative means to obtain general information or address issues that arise in the context of 
the regulatory process.  The circumstances, contacts, and resources are described in detail in 
section VIII., Additional Contacts. 
 
CDER and CBER are aware that at times sponsors wish to communicate directly with reviewers 
assigned to their INDs to expedite the exchange of information and to facilitate timely progress 
in their drug development programs.  Such communications are strongly discouraged and 
sponsors should not directly contact FDA reviewers.  It is critical that sponsor inquiries be 
directed to the appropriate FDA RPM to ensure that requests are appropriately communicated to 
and considered by the review team members, including supervisors as appropriate.  CDER and 
CBER strive to provide timely and accurate advice and feedback to sponsors that represent the 
review teams current thinking on the issue, and this is best accomplished by adhering to the 
communication procedures described above and throughout this guidance.  Direct contact by 
sponsors with review team members may interrupt their work on other critical assignments and 
may lead to responses that have not been vetted by the appropriate members of the review teams 
and supervisors.  The feedback and advice provided may thus not accurately or comprehensively 
capture FDAs thinking or be properly documented in the IND.   
 
In rare cases, however, and with supervisory approval, it may be appropriate for FDA review 
team members to communicate directly with sponsors regarding specific, limited issues related 
to their drug development programs.  In all such cases, the FDA review team member will 
document the conversation in a memorandum to the IND and provide a copy of that record to the 
appropriate FDA RPM for sharing with the rest of the FDA review team.  Decisions to allow 
such limited direct contact between sponsors and FDA reviewers will be made on a case-by-case 
basis by FDA management and represent an exception to usual best practices. 
 
                                                 
12 21 CFR 10.75 
6  Contains Nonbinding Recommendations 
Independent consultants in the pharmaceutical field, whether working on behalf of specific 
sponsors or on their own behalf, who have basic drug development questions should use existing 
FDA resources listed in section VII.I, Resources for Sponsors, and/or the contacts listed in 
section VIII., Additional Contacts, if needed.  An independent consultant working on behalf of a 
specific sponsor who seeks advice regarding the sponsors drug development program should be 
authorized to do so in writing by the sponsor before initiating contact with FDA staff and should 
follow the procedures outlined above (i.e., direct requests to the appropriate FDA RPM).13 
 
If a sponsor encounters challenges in obtaining timely feedback to inquiries to an FDA RPM, it 
should contact the project managers next level supervisor (e.g., the review divisions chief of 
the project management staff (CPMS) or branch chief).  This generally results in timely 
resolution of the issue.  If a sponsor continues to encounter challenges in obtaining timely 
feedback, it may wish to communicate with review team supervisors or division or office 
management officials.  Such requests generally should be directed to the review divisions 
CPMS/branch chief so they can be communicated appropriately to the requested official and a 
mutually agreeable time can be arranged for a conversation by telephone.  It is helpful if the 
sponsor provides the review divisions CPMS/branch chief with background information on the 
purpose of the request to assist in determining the proper official to handle the call and also to 
allow the FDA official to adequately prepare for the call to make most efficient use of the 
allotted time.  All such communications will be documented by either the review divisions 
CPMS/branch chief or the designated FDA official to the IND and shared, as appropriate, with 
other review team members. 
 
To streamline communications and have a mutual understanding of the preferences and 
expectations for sponsor and FDA communications during drug development, FDA recommends 
that sponsors and FDA RPMs, particularly the review division RPMs responsible for managing 
the applications, establish a mutually agreeable communication strategy.  The communication 
strategy can be established early in the development program (i.e., around the time of IND 
submission) and adjusted at any time when there are outstanding issues (e.g., feedback on a new 
protocol) or modifications to the development program that might warrant more frequent or 
possibly less frequent interactions.  A communication strategy might include the preferred 
method(s) (e.g., email versus telephone) and frequency of communications and/or approaches for 
managing information requests and responses (e.g., one request at a time versus bundled 
requests).  As part of a communication strategy, sponsors and FDA should share contact 
information for alternative backups (e.g., the CDER review division CPMS or the CBER 
alternative project management staff) and the mutual expectations for the timing of responses to 
inquiries (see section VI., General Expectations for Timing of Communications). 
 
A formal communication plan may be established for drug applications reviewed in the PDUFA 
Program for Enhanced Review Transparency and Communication for NME NDAs and Original 
BLAs (the Program)14 and for biologic biosimilar applications reviewed under the Biosimilar 
User Fee Act (BsUFA).  If established, the plan should be discussed and agreed to at the 
                                                 
13 21 CFR 312.23(a)(1)(viii) describes the information to provide in an IND when a sponsor has transferred any 
obligations for the conduct of any clinical study to a contract research organization. 
 
14 https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm327030.htm 
7  Contains Nonbinding Recommendations 
presubmission meeting.  The formal communication plan contains a mutually agreed-upon 
alternative approach to the timing and nature of interactions and information exchange between 
FDA and the sponsor.  The formal communication plan should specify those elements of the 
Program that FDA and the sponsor agree are unnecessary for the application under review, if 
applicable. 
 
For breakthrough therapy-designated drugs, FDA and the sponsor should establish a formal 
communication plan at the initial comprehensive multidisciplinary meeting.  The plan includes 
the expectations on the timing and format of interactions and information exchange.  As is the 
case for all drug development plans, the review division RPM is the primary point of contact.15 
 
 
V.  TYPES OF ADVICE THAT ARE APPROPRIATE FOR SPONSORS TO SEEK 
 
During the life cycle of drug development, sponsors routinely solicit feedback from FDA on both 
scientific and regulatory issues.  The breadth and frequency of advice sought can vary according 
to the experience of the sponsor, as well as the novelty and development stage of the proposed 
drug.  During the IND phase of drug development, sponsors often solicit advice at critical 
junctures in their development programs.  These topics include, but are not limited to the 
following: 
 
  Regulatory (e.g., plans for submission of proprietary name requests, plans to defer or 
waive specific studies, development plans with other FDA centers (e.g., the Center for 
Devices and Radiological Health for combination products), applicability of an expedited 
program)  
 
  Clinical/statistical (e.g., planned clinical trials to support effectiveness compared to a 
placebo or to demonstrate noninferiority to an active control, validity of outcomes and 
endpoints, trial size, enrichment designs) 
 
  Safety (e.g., safety issues identified in nonclinical studies and early clinical trials, 
immunogenicity, size of the overall safety database, concerns related to particular 
populations, postapproval pharmacovigilance plans, risk evaluation and mitigation 
strategies (REMS), plans for human factors studies, issues related to evaluation of abuse 
potential)  
 
  Clinical pharmacology and pharmacokinetics (e.g., dose selection and population, use in 
specific populations, drug-drug interactions) 
 
  Nonclinical pharmacology, pharmacokinetics, and toxicology (e.g., genetic toxicology, 
reproductive and developmental toxicology, carcinogenicity, mechanism of action) 
 
  Product quality (e.g., analytical similarity assessment, proposed shelf life and stability 
studies, delivery systems, characterization of drug substance/product, facility compliance 
                                                 
15 See the guidance for industry Expedited Programs for Serious Conditions  Drugs and Biologics. 
8  Contains Nonbinding Recommendations 
with good manufacturing practices, comparability of lots used in clinical trials and 
commercial lots) 
 
  Pediatrics (e.g., proposed pediatric development plan, dosing) 
 
Because FDA resources are limited, sponsors are strongly encouraged to first seek answers to 
their scientific and regulatory questions from the multitude of resources available to them, such 
as the FDA resources described in section VII.I., Resources for Sponsors.  Sponsors also can 
employ an independent consultant for assistance in conceiving strategic drug development and 
regulatory plans.  Doing this allows both sponsors and FDA to conserve their respective 
resources to address the more complex and challenging drug development and regulatory science 
issues.  
 
When soliciting feedback from FDA, sponsors should keep in mind the following: 
 
  FDA policy positions are typically documented and described in FDA guidances, 
MAPPs, and SOPPs.  
 
  Complex scientific and technical drug development questions should be directed to the 
FDA RPM, typically the review division RPM, via either a submission or through the 
formal meeting request process. 
 
  General questions that cannot be answered by using existing resources can be directed to 
an FDA RPM, to the designated enhanced communication staff within each FDA center, 
or to CDERs Division of Drug Information (DDI) (see section VIII., Additional 
Contacts).  Depending on the nature and complexity of the question(s), FDA will either 
respond to the question(s) or redirect the sponsor to an alternative pathway for receiving a 
response (e.g., other FDA subject matter expert, formal meeting request process). 
 
 
VI.  GENERAL EXPECTATIONS FOR TIMING OF COMMUNICATIONS 
 
FDA recognizes that timely and effective communication during the IND phase of drug 
development provides sponsors with information they seek to inform the design of studies and 
trials, as well as product quality information, intended to support approval of a future marketing 
application.  FDA staff therefore try to respond to sponsor questions promptly, while balancing 
FDA public health priorities and other work obligations.  Note that responses to safety-related 
inquiries will be prioritized higher than other inquiries in alignment with FDAs previously 
stated primary responsibilities with respect to INDs. 
 
During the course of these collaborative interactions, sponsors sometimes pose questions to FDA 
that they perceive as simple or clarifying questions with the expectation that only minimal time 
will be needed for an FDA response.  However, what may appear to the sponsor to be simple or 
clarifying questions may be more complex and necessitate significant review and communication 
among review team members, including internal meeting(s), before an answer can be provided.  
For example, questions that involve interpretation of regulations and statutes, or application of 
9  Contains Nonbinding Recommendations 
existing FDA policy to novel circumstances, are often complex (not simple) and therefore 
demand significant vetting and response time.  Similarly, questions involving combination 
products usually demand additional time to solicit and consider feedback from multiple FDA 
centers and offices.  In all cases, FDA needs to take a thoughtful approach to answering sponsor 
questions both efficiently and comprehensively, particularly when the questions could have an 
important effect on critical decisions in development programs or that represent FDA views 
related to the evidence that will be used to support marketing.   
 
Complex scientific/technical, policy, or regulatory questions are best posed to FDA in either 
requests for formal meetings or in formal submissions.  Traditionally, FDA has taken a 
collaborative approach to responding to questions included in meeting packages and in 
submissions, according to their respective prespecified timelines as follows:  
 
  Meetings.  Communications that involve sharing results and information at critical 
milestones during drug development or at the appropriate stage of development for a 
biosimilar product, or are necessary for a stalled development program to proceed, are 
best addressed in formal meetings between FDA and sponsors (e.g., face-to-face meeting, 
teleconference, or written response only (WRO)).  Timelines for FDA feedback to 
sponsors via the formal meeting process are described in the PDUFA and BsUFA 
agreements16 and in FDAs formal meetings guidances.17  This FDA feedback includes:  
preliminary comments, final meeting minutes, and responses to questions posed in WRO 
requests. 
 
  Submissions.  Hundreds of supporting documents might be submitted to an IND during 
its life cycle that require varying degrees of review and for which communication with 
the sponsor may be needed.  Some submissions have regulatory-mandated timelines for 
reviewing and providing feedback to the sponsor that are described by statute or 
regulation (e.g., some safety-related submissions, complete response to clinical hold18) 
while other submissions have FDA-established goals for review and feedback (e.g., in a 
MAPP).  These latter submission types include some safety-related submissions, drug 
development submissions without regulatory timelines where communication to the 
sponsor is often critical and recommended (e.g., a new protocol or protocol amendment), 
and other submissions where communication with the sponsor may be needed. 
 
For all other sponsor inquiries that are received via telephone, email, or in a submission without 
a prespecified review timeline described in a MAPP and include specific questions for FDAs 
consideration, the FDA RPM will strive to acknowledge such communications via telephone or 
email within 3 business days of receipt by the FDA RPM.  FDAs acknowledgment will: 
 
                                                 
16 See https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm or 
https://www.fda.gov/forindustry/userfees/biosimilaruserfeeactbsufa/default.htm.  
 
17 See the guidances for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA 
Products and Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.   
 
18 21 CFR 312.42(e) 
10  Contains Nonbinding Recommendations 
  Include the response itself, if available within the acknowledgment time frame;  
 
  Include an estimated time frame for division response to question(s);  
 
  Inform the sponsor that its question(s) involve consultation with other FDA parties (e.g., 
policy questions where legal input is necessary, questions about combination products 
where other centers or offices are involved) and therefore an estimated response time 
frame will be forthcoming;  
 
  Recommend that the sponsor submit a formal meeting request (e.g., face to face, 
teleconference, or WRO); or 
 
  Recommend that the sponsor contact another specialized functional area in FDA (e.g., 
import/export, orphan products or rare diseases, pediatric therapeutics) 
 
Similarly, sponsors should: 
 
  Acknowledge receipt of FDAs information requests (written or otherwise)  
  Provide the appropriate FDA RPM with an estimated response time   
 
Because sponsor delays in responding, or lack of response, to FDA information requests can 
negatively affect later development, it is equally important for sponsors to respond completely 
and promptly to FDA requests. 
 
Note that although FDA will attempt to adhere to all established or estimated response timelines, 
FDA may not always be able to meet these timelines.  If unexpected complex issues arise during 
the review of a submission, FDA will provide an answer when it is fully developed, rather than 
adhering to a timeline when doing so may provide incomplete information to a sponsor.  The 
timing of FDA response may also be negatively affected if the review team experiences an 
unexpected shift in work priorities or team staffing.  In these cases, the FDA RPMs fully intend 
to keep sponsors apprised of changes to the estimated response timeline.  When sponsors 
encounter delays in obtaining an FDA response to questions for which they have solicited 
feedback, the following stepwise approach should be taken: 
 
  Contact the appropriate FDA RPM, typically the review division RPM, for a status 
update after the expected amount of time for FDA response has passed (e.g., the timelines 
described in a MAPP); 
 
Or 
 
Contact the appropriate FDA RPM, typically the review division RPM, for a status 
update after the estimated response time has passed (i.e., the estimated FDA-response 
date communicated to the sponsor previously) 
 
  Contact the appropriate FDA RPMs next level supervisor for assistance in eliciting a 
response from the FDA RPM 
11  Contains Nonbinding Recommendations 
 
  Contact the appropriate division or office management officials for assistance in eliciting 
a response from the FDA RPMs next level supervisor 
 
  Contact CDERs Enhanced Communication Team (ECT) or CBERs Ombudsman for 
assistance should the division or office management officials fail to respond 
 
 
VII.  BEST PRACTICES AND COMMUNICATION METHODS 
 
Effective and timely communication between FDA and sponsors promotes understanding of 
mutual goals and is invaluable to the drug development process.  Central to this is the ability to 
communicate clearly, both verbally and in writing, inside and outside the formal meeting format.  
It is also important that FDA and sponsors have a common understanding of terms and phrasing 
used in communications with each other, and that they are used consistently by both parties.  In 
FDA communications related to INDs, as a best practice FDA staff will: 
 
  Use words such as shall, must, required, or requirement to convey a statutory or 
regulatory requirement.    
 
  Use the following words to communicate advice (e.g., on trial design), comments, or 
current thinking:  advisable, critical, important, may be appropriate, should, consider, 
discourage, encourage, prefer, recommend, suggest, or urge.  Because FDA has the 
advantage of viewing the spectrum of drug development data and information across 
sponsors, indications, and drug classes, FDA is able to communicate advice to sponsors 
with that expertise in mind, while upholding commercial confidentiality. 
 
The IND phase of drug development is typically a multiyear process, and FDA recognizes that 
new data will become available and that scientific and regulatory advances and changes in 
clinical practice may occur during this time.  Because sponsors are ultimately responsible for 
managing the overall development program for their proposed drugs, sponsors should monitor 
for advances in the field and/or changes in FDA guidance, and inquire if those changes may 
necessitate changes in prior FDA recommendations for their development programs.  Although 
FDA reviewers consider new information and revise recommendations as needed, they try to 
support and adhere to their prior critical recommendations when appropriate.  Changes in 
recommendations are expected to be based on new scientific or safety information or advances in 
clinical practice that make earlier FDA recommendations outdated, inappropriate, or unethical.  
In such cases, review staff via the FDA RPMs should inform sponsors in writing of these 
changes and the rationale behind the changes. 
 
Both FDA and sponsors use various communication methods to focus discussions to effectively 
exchange information and resolve issues.  Because there are different business cultures, 
communication styles, preferences, and documentation needs, there is no single best 
communication method.  Rather, there are best practices that enhance each method.  For 
example, telephone communication between a sponsor and the FDA RPM may be more effective 
than email for time-sensitive matters.  A best practice would be to follow up after the telephone 
12  Contains Nonbinding Recommendations 
call with a written communication (e.g., email, submission, correspondence) so that there is 
documentation of decisions, agreements, or action items that arose during the interaction.  
 
The best practices and communication methods described within this section are intended to 
identify means of exchanging information in ways that permit efficient, timely, and targeted 
review of and response to sponsors questions.  Communication via any of these methods (except 
meetings where numerous attendees participate) should be conducted via the FDA RPM, 
typically the review division RPM, rather than FDA reviewers, team leaders, or senior 
management to ensure that the advice is appropriately vetted and documented. 
 
A.  Formal Meetings Between FDA and Sponsors 
 
Meetings are useful in resolving questions and issues raised during the life cycle of drug 
development.  There are important reasons for sponsors to discuss development plans with FDA.  
FDA can provide valuable scientific and regulatory advice, resulting in more efficient and robust 
development programs.  FDA can also help sponsors understand the evidence that will be 
necessary to demonstrate effectiveness, safety, highly similar or no clinically meaningful 
differences, and product quality.  It is critical for sponsors to ascertain FDAs views on the 
applicable statutory and evidentiary requirements well in advance of submission of a marketing 
application to ensure an efficient development program.   
 
Meetings between FDA and a sponsor at critical junctures in drug development can be especially 
helpful in minimizing wasteful expenditures of time and resources and thus in speeding the drug 
development and evaluation process.   
 
These milestone meetings under PDUFA include pre-IND, end-of-phase 1 (EOP1), end-of-phase 
2 (EOP2), and pre-NDA/BLA meetings.  
 
  Pre-IND meetings are valuable for understanding the mechanism of actions of the drug 
and possible study designs and initiating dialogue regarding drug development in its early 
stages.  They can prevent clinical hold issues from arising and aid sponsors in developing 
a complete IND.  FDA encourages sponsors to request a pre-IND meeting for the 
following:  a drug not previously approved or licensed; a new molecular entity (NME), 
especially one with a novel pharmacologic mechanism; a planned marketing application 
intended to be submitted under the 505(b)(2) regulatory pathway; drugs for which it is 
critical to public health to have an effective and efficient drug development plan (e.g., 
drugs for counter-terrorism, drugs to treat life-threatening or severely debilitating 
illnesses); drugs with substantial early development outside the United States; a planned 
human factors development program; and drugs with adequate and well-controlled trials 
to support a new indication.  However, a sponsor of any IND can request a pre-IND 
meeting.  
 
  EOP1 meetings are useful to review and reach agreement on the design of phase 2 
controlled clinical trials and to discuss issues related to the proposed drug development 
program, including pediatric study plans, as appropriate.  Because of limited resources, 
FDA has traditionally encouraged sponsors to request an EOP1 meeting only for drugs 
13  Contains Nonbinding Recommendations 
intended to treat life-threating and severely debilitating illnesses, particularly situations 
where approval based on phase 2 trials or accelerated approval may be appropriate.19 
 
  EOP2 meetings are of considerable importance in determining the safety of, and 
sufficiency of data (e.g., on dose selection) for, proceeding to phase 3, and for planning a 
complete and well-designed phase 3 development program.  EOP2 meetings serve to 
evaluate the phase 3 plan and protocols, the adequacy of current studies and plans to 
assess pediatric safety and effectiveness, evaluate the human factors validation plan, and 
identify any additional information necessary to support a marketing application for the 
uses under investigation.  FDA encourages sponsors to request an EOP2 meeting for 
NMEs or major new uses of marketed drugs.  However, a sponsor of any IND can request 
an EOP2 meeting. 
 
  Pre-NDA/BLA meetings are helpful in acquainting FDA reviewers with the format and 
content of the planned marketing application, including labeling and risk management 
activities (if applicable), presentation and organization of data, dataset structure, 
acceptability of data for submission, as well as the projected submission date of the 
marketing application.  They are also intended to uncover major issues, identify studies 
intended to establish the drugs safety and effectiveness, discuss the status of pediatric 
studies, and discuss statistical analysis methods, or the results of analyses.  FDA 
encourages sponsors to request pre-NDA/BLA meetings for all planned marketing 
applications, particularly applications to be reviewed under the Program. 
 
Meetings under BsUFA include BIA and BPD Type 1 through Type 4 meetings.  These meetings 
are intended to support an iterative process of interactions during the biosimilar development 
phase.  They are based on the stage of development of the biosimilar product and on the amount 
and type of data and information provided to support the meeting.     
 
  A BIA meeting is an initial assessment limited to a general discussion regarding whether 
licensure under section 351(k) of the Public Health Service Act (PHS Act) may be 
feasible for a particular product, and, if so, general advice on the expected content of the 
development program.  This meeting type does not include any meeting that involves 
substantive review of summary data or full study reports. 
 
  A BPD Type 1 meeting is a meeting that is necessary for an otherwise stalled drug 
development program to proceed (e.g., meeting to discuss clinical holds, dispute 
resolution meeting, a special protocol assessment meeting, or a meeting to address an 
important safety issue). 
 
  A BPD Type 2 meeting is a meeting to discuss a specific issue (e.g., proposed study 
design or endpoints) or questions where FDA will provide targeted advice regarding an 
ongoing BPD program.  This meeting type can include substantive review of summary 
data, but does not include review of full study reports. 
 
                                                 
19 21 CFR part 312, subpart E 
14  Contains Nonbinding Recommendations 
  A BPD Type 3 meeting is an in-depth data review and advice meeting regarding an 
ongoing BPD program.  This meeting type includes substantive review of full study 
reports, FDA advice regarding the similarity between the proposed biosimilar biological 
product and the reference product, and FDA advice regarding additional studies, 
including design and analysis.  
 
  A BPD Type 4 meeting is a presubmission meeting to discuss the format and content of a 
complete application for an original biosimilar biological product application under the 
Program or supplement submitted under 351(k) of the PHS Act.  The purpose of this 
meeting is to discuss the format, content, and presentation of the planned submission and 
other items, including identification of those studies that the sponsor is relying on to 
support a demonstration of biosimilarity or interchangeability, discussion of any potential 
review issues, identification of the status of ongoing or needed studies to adequately 
address the Pediatric Research Equity Act, and acquainting FDA reviewers with the 
general information to be submitted in the marketing application (including technical 
information). 
 
Feedback to sponsors via the formal meeting process is provided in three main formats:  face-to-
face meetings, teleconferences/videoconferences, and WRO responses.  Detailed information 
about meeting requests, packages, scheduling, preparation, conduct, and documentation (meeting 
minutes) are described in other guidances.20  The timelines are described in the PDUFA and 
BsUFA agreements. 
 
The following represent meeting-related best practices for the various meeting formats. 
 
  Meeting Requests 
 
  Before requesting a meeting with FDA, sponsors should use the extensive sources of 
drug development information that are publically available.  See section VII.I., 
Resources for Sponsors. 
 
  Sponsors are encouraged to request feedback via formal meetings with FDA at the 
major drug development milestones under PDUFA or at the appropriate stage of a 
biosimilar development program under BsUFA as described above.  FDA typically 
grants meeting requests at these major milestones or at the appropriate stage of 
development of a biosimilar product. 
 
  Sponsors should only submit milestone meeting requests or biosimilar-related 
meeting requests when drug development has progressed to the point where a full 
discussion of issues germane to that development stage is possible.  Premature 
meeting requests are often denied by FDA or are re-categorized by FDA as a different 
meeting type. 
 
                                                 
20 See the guidances for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA 
Products and Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants. 
15  Contains Nonbinding Recommendations 
  In lieu of a traditional meeting with FDA (i.e., face to face or teleconference), 
sponsors also can seek feedback through WRO requests for any type of PDUFA 
meeting (e.g., Types A, B, B (EOP), or C) or for BIA and BPD Type 2 BsUFA 
meetings.21  FDA may also exercise discretion in converting a traditional meeting 
request for a pre-IND or Type C meeting to WRO responses under PDUFA.  The 
number of questions posed in a WRO request should be no more than what would be 
reasonably expected to be addressed in a traditional meetings allotted duration. 
 
  Sponsors must outline the purpose of the meeting in the meeting request.22  
 
  Sponsors meeting requests should include their preferred dates and must include the 
requested FDA attendees.23  The FDA RPMs should take these preferences into 
consideration when scheduling meetings. 
 
  Sponsors should try to anticipate future needs and, to the extent practical, combine 
discussion of drug development issues into the fewest possible meetings. 
 
  Meeting Packages.  Premeeting preparation is critical for achieving a successful meeting 
with productive discussion and exchange of information. 
 
  Sponsors should submit meeting packages for all meeting formats, including WRO, 
within the timelines described in the PDUFA and BsUFA agreements.  FDA grants 
and schedules meetings expecting that appropriate information to support the 
discussion will be submitted with sufficient time for review and preparatory 
discussion.  Thus, the meeting or WRO may be canceled or denied if the meeting 
package is inadequate or not received within the specified timelines. 
 
  Sponsors should submit a limited number of clearly worded and targeted questions 
that directly address concerns about the drug development programs.  The number of 
questions in a meeting package should not exceed what can be reasonably discussed 
within the duration of the allotted meeting time.  The information and data provided 
by a sponsor in the meeting package should facilitate FDA responses to the questions 
asked. 
 
  Sponsors meeting packages should be well organized and tabbed or bookmarked to 
enhance the reviewers navigation within the packages both in preparation for and 
during the meetings. 
 
  The FDA RPM should send preliminary responses to sponsor questions before the 
meeting so that the meeting time can be dedicated to unresolved issues for which 
                                                 
21 Ibid. 
 
22 See PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022 (PDUFA VI) 
available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf. 
 
23 Ibid. 
16  Contains Nonbinding Recommendations 
more discussion is needed.  The timelines for preliminary responses are described in 
the PDUFA and BsUFA agreements and in FDAs formal meetings guidances.  In the 
preliminary responses, FDA should provide high-level recommendations for 
important issues identified during the review of the meeting package, even if 
questions concerning those issues were not explicitly posed by the sponsor. 
 
  Meeting Conduct 
 
  Sponsor presentations generally are not needed because the information necessary for 
review and discussion should have been included in the meeting package.  Instead, 
valuable meeting time should be reserved for a focused discussion of issues identified 
in the meeting package, particularly those that remain unresolved after FDAs 
preliminary responses have been sent to the sponsor or issues that have been raised in 
FDAs responses.  
 
  The meeting facilitator should take into account the total meeting time available and 
keep the discussion focused on the questions posed by the sponsor in the meeting 
package, as well as relevant FDA preliminary responses.  During the course of the 
meeting, the sponsor generally should not ask substantive questions that were not 
included in the meeting package, or present new data or information that was not 
previously provided to FDA or requested by FDA in its preliminary comments.  Such 
questions and presentation of new data generally are best addressed in a subsequent 
communication or meeting request to FDA.    
 
  Pre-IND, pre-NDA/BLA, BIA, and BPD Type 4 meetings should include a discussion 
of what constitutes a complete application to ensure there is mutual understanding 
and agreement on the contents of a complete application. 
 
  Pre-NDA/BLA meetings for applications reviewed in the Program under PDUFA 
should include preliminary discussions of REMS or other risk management actions, 
the development of formal communication plans, and where applicable, timelines for 
review activities associated with a scheduling recommendation under the Controlled 
Substances Act for drugs with abuse potential.  They should be held sufficiently in 
advance of the planned submission of the application to allow for meaningful 
consideration of FDA feedback and generally should not occur sooner than 2 months 
before the planned submission of the application. 
 
  BPD Type 4 (pre-351(k) BLA) meetings for applications reviewed under BsUFA 
should include preliminary discussions of REMS, where applicable, patient labeling 
(e.g., Medication Guide and Instructions for Use), and, where applicable, the 
development of formal communication plans.  They should be held in sufficient 
advance of the planned submission of the application to allow for meaningful 
consideration of FDA feedback, and generally should not occur sooner than 2 months 
before the planned submission of the application. 
 
17  Contains Nonbinding Recommendations 
  Sponsors and/or FDA attendees should summarize important discussion points, 
agreements, clarifications, and action items either at the end of the meeting or after 
the discussion of each question.  It is helpful for the sponsor to provide an overall 
summary of the discussion at the end of the meeting to ensure that there is mutual 
understanding of meeting outcomes and action items. 
 
  Meeting Minutes.  FDAs documentation of meeting outcomes, agreements, 
disagreements, and action items is critical to ensuring that this information is preserved 
for meeting attendees and future reference, because the FDA minutes are the official 
record of the meeting.  
 
  FDA minutes of meetings with sponsors are summaries of the important elements of 
the discussion and document the identified agreements, disagreements, and action 
items raised during the meeting.  Meeting minutes are not intended to represent 
transcripts of the meetings.  The summarized elements need not be described in 
exhaustive detail.  
 
  FDA RPMs will use established meeting minute templates to ensure that all important 
meeting information is captured. 
 
  FDA RPMs will issue meeting minutes, or provide responses to WRO requests, 
according to the timelines described in the PDUFA and BsUFA agreements.  
 
  If there is a significant difference in the sponsors and FDAs understanding of the 
content of the meeting minutes, sponsors should seek resolution by notifying FDA of 
their understanding of the discrepancy. 
 
B.  Written Correspondence From FDA 
 
FDA RPMs will use established letter templates to ensure consistency and accuracy in regulatory 
communications.  FDA RPMs should send courtesy copies of written FDA correspondence to 
sponsors via secure email when the correspondence communicate regulatory actions (e.g., 
clinical hold) or are time-sensitive.  The FDA RPM should send the courtesy copy via fax if 
secure email has not been established by the sponsor. 
 
C.  Submissions From Sponsors 
 
During the life cycle of IND drug development, sponsors submit an array of regulatory 
submissions to FDA that require varying degrees of review, response, and/or feedback.  The 
regulations under 21 CFR part 312, subparts B and C, describe types of submissions that are 
required during the IND phase of drug development.24  Some are administrative in nature (e.g., 
investigator information, meeting request, request for inactivation, annual reports), others focus 
on patient safety (e.g., IND safety reports, response to clinical hold deficiencies), and others 
describe clinical and nonclinical trial plans (e.g., protocols and protocol amendments, pediatric 
study plans, information amendments including drug quality amendments) for which sponsors 
                                                 
24 For example, 21 CFR 312.23, 312.30, 312.31, 312.32, 312.33, and 312.42. 
18  Contains Nonbinding Recommendations 
may seek FDA comment and advice.  Detailed information about the review of IND 
submissions, including FDA-established or regulatory-mandated review timelines, is described 
in a CDER MAPP.25 
 
Sponsors must adhere to required timelines for their submissions (e.g., IND safety reports, 
annual reports).26  In addition, FDA regulations describe the timing requirements for submitting 
a new protocol as an amendment to an IND that is already in effect or for when a new 
investigator is added to carry out a previously submitted protocol.27  When several submissions 
of new protocols or protocol changes are anticipated during a short period, the sponsor is 
encouraged, to the extent feasible, to include these all in a single submission.28  Information 
amendments to the IND should be submitted as necessary but, to the extent feasible, not more 
often than every 30 days.29 
 
FDA regulations describe general principles of, as well as content and format requirements for, 
INDs.30  Complete and well-organized sponsor submissions, in a format appropriate for scientific 
review, can increase the efficiency of FDA review.  Form FDA 1571 is an administrative form 
that should accompany most IND submissions to indicate the content and purpose.31  All IND 
submissions should include overall summaries sufficient to allow FDA staff to understand the 
regulatory and developmental context of the submissions.  The summary should list the 
objectives of the submission, and include any questions the sponsor would like addressed in 
writing.  Questions to FDA should be framed within the regulatory context to allow reviewers to 
understand why the issue is important. 
 
FDA encourages sponsors to identify issues or areas of concern in their submissions by 
describing them fully and soliciting feedback on specific areas of concern where further 
progression in drug development depends largely on receiving FDA feedback.  Sponsors run the 
risk of not receiving timely FDA feedback, and therefore conducting inefficient or inadequate 
development programs, if they omit important information, do not identify the regulatory intent 
of the submissions, or provide insufficient detail.   
 
                                                 
25 CDER MAPP 6030.9 Good Review Practice:  Good Review Management Principles and Practices for Effective 
IND Development and Review. 
 
26 21 CFR part 312 
 
27 21 CFR 312.30(b) 
 
28 21 CFR 312.30(e) 
 
29 21 CFR 312.31(c) 
 
30 21 CFR 312.22 and 312.23 
 
31 21 CFR 312.23(a)(1) 
19  Contains Nonbinding Recommendations 
D.  Acknowledging Receipt of Communications 
 
FDA RPMs will send written acknowledgments of receipt of certain submissions that have 
review timelines (e.g., charging request, request for fast track designation).  They will also strive 
to acknowledge receipt of questions received from sponsors via telephone calls, emails, and 
other submissions within 3 business days of receipt.  The acknowledgment may include the 
response itself, an estimated response time frame, notification that the question(s) have been 
consulted to other offices or centers with an undetermined response time frame, a 
recommendation to submit the questions via a formal meeting request, or redirection to another 
specialized functional area in FDA (e.g., import/export). 
 
Sponsors should likewise acknowledge receipt of FDA information requests and provide an 
estimated response time. 
 
E.  Email Between FDA and Sponsors 
 
Use of secure email allows transparent and complete communication between FDA and sponsors 
although it is not a substitute for formal submissions (e.g., new INDs and amendments); formal 
submissions should be submitted to the respective centers document room (paper submissions) 
or via the electronic gateway, as applicable.  FDA communication via unsecure email cannot 
include confidential commercial information (e.g., trade secrets, manufacturing, or patient 
information).  Therefore, sponsors should establish secure email with FDA to allow for 
communications that may include confidential commercial information.32 
 
Sponsors should contact the Office of Information Management and Technology (OIMT) to 
request secure email.33  OIMT provides requestors with general industry standard practices and 
instructions on how to obtain FDA digital certificates but does not otherwise provide outside 
support.  If a digital certificate has expired, sponsors should send a signed message with the 
current digital signature to the email address provided on the Electronic Regulatory Submission 
and Review web page. 
 
F.  General Telephone Calls Between FDA and Sponsors 
 
General or administrative questions are suitable for communications between sponsors and FDA 
RPMs via telephone.  However, when complex, regulatory, or technical issues are discussed 
during the course of a telephone conversation between the sponsor and the FDA RPM, the caller 
should follow up with a written communication (e.g., email, sponsor submission, FDA 
correspondence) to document the discussion and/or respond to information requested during the 
conversation.  Telephone calls, even when documented in the administrative record, are not a 
substitute for formal submissions such as a formal meeting request, IND amendment, or a 
                                                 
32 Sponsors that are unable to establish secure email should contact the appropriate review division to discuss 
acceptable alternative arrangements for communication. 
 
33 See the Electronic Regulatory Submission and Review web page for contact information 
(https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/
ucm2007043.htm). 
20  Contains Nonbinding Recommendations 
request for a special protocol assessment.  Depending on the nature of the questions presented 
during the conversation, the sponsor may be referred to the formal meeting process for a fuller 
discussion of the issue(s) with additional review staff and management. 
 
Both FDA RPMs and sponsors should exchange contact information for communicating time-
sensitive issues (e.g., notification of clinical hold).  This contact information should be included 
in out-of-office messages, whenever appropriate.  This is particularly important during the 30-
day period after submission of an original IND. 
 
G.  Faxes Between FDA and Sponsors 
 
Faxes can be used when secure email has not been established between FDA and sponsors 
although they are not substitutes for formal submissions (e.g., new INDs and amendments); 
formal submissions should be submitted to the respective centers document room (paper 
submissions) or via the electronic gateway, as applicable.  Before transmitting faxes, sponsors 
and FDA RPMs should contact their respective counterparts to arrange for confirmation of 
receipt.  Given the volume of communications received by FDA and sponsors, this reduces the 
possibility that faxes will be overlooked.  To facilitate accurate and timely routing, coversheets 
should be included with faxes. 
 
H.  Use of Out-of-Office Messages by FDA and Sponsors 
 
Sponsors and FDA staff should alert others to their unavailability by using email or voicemail 
out-of-office messages, or by communicating a planned absence in advance by email or 
telephone.  The messages should include an expected return time and contact information for 
other staff that may be able to assist in the interim, particularly for time-sensitive 
communications (e.g., notification of clinical hold).  FDA RPMs should also include contact 
information for their divisions CPMS in CDER or the alternative project management staff in 
CBER. 
 
I.  Resources for Sponsors 
 
To disseminate a broad range of information in a manner that can be easily and rapidly accessed 
by interested parties, FDA develops and maintains web pages, portals, and databases, and 
participates in interactive media as a means of providing self-service tools for its stakeholders, 
including sponsors.  Sponsor use of these tools allows FDA to focus its limited resources on 
providing advice regarding scientific and regulatory issues that fall outside of established 
guidance, policy, and procedures. 
 
1.  FDA Guidances 
 
FDA uses guidance documents to explain its current thinking on policy, scientific, and/or 
regulatory issues.34  FDA guidances are useful for industry, FDA staff, and other stakeholders 
who may refer to them to address such matters as the design, manufacturing, and testing of 
regulated products; scientific issues; format and content of marketing applications; and 
                                                 
34 21 CFR 10.115 
21  Contains Nonbinding Recommendations 
inspection and enforcement policies.  In general, FDA guidances do not establish legally 
enforceable responsibilities.  Instead, guidances describe FDAs current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory requirements 
are cited.  Stakeholders can use an alternative approach if the approach satisfies the requirements 
of applicable laws and regulations.  For available guidances, see the FDA Drugs guidance web 
page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.  
 
2.  FDA Policy and Procedures 
 
CDERs MAPPs document CDER internal policies and procedures, while CBERs SOPPs 
document CBER internal policies and procedures.  Both MAPPs and SOPPs are made available 
to the public for purposes of transparency regarding FDA processes.   
 
  A listing of CDER MAPPs can be found at 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/C
DER/ManualofPoliciesProcedures/default.htm  
 
  A listing of CBERs SOPPs can be found at 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformati
on/ProceduresSOPPs/default.htm  
 
3.  FDA Basics for Industry 
 
The FDA website contains two web pages that provide basic information for industry.   
 
The FDA Basics for Industry web page provides basic information about the regulatory process 
in addition to resources to better understand how to work with FDA.  It is intended to improve 
communication between FDA and industry.  The FDA Basics for Industry web page can be 
found at https://www.fda.gov/forindustry/fdabasicsforindustry/default.htm.  
 
The Investigator-Initiated Investigational New Drug (IND) Applications web page includes links 
to information for investigators about submitting INDs to FDA and can be found at 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApprove
d/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm343349.htm.   
 
4.  FDA Interactive Media 
 
FDA uses interactive media to communicate information about emerging science, new policies, 
procedures, guidances, MAPPs, SOPPs, and public advisory committee meetings or workshops 
that affect or can inform drug development.  To stay informed, sponsors and review staff should 
subscribe to interactive media.  A listing of interactive media resources can be found at 
https://www.fda.gov/NewsEvents/InteractiveMedia/default.htm.  
 
22  Contains Nonbinding Recommendations 
5.  FDA Presentations 
 
CDERs Presentation Library provides access to information about FDA policies and procedures 
presented to external audiences at meetings, conferences, and workshops sponsored or co-
sponsored by FDA.  The information covers a range of topics, including, for example, user fees, 
drug advertising and marketing, genomics, drug quality, and nonprescription drugs.  Materials 
and overviews from some of these meetings are listed in the Presentations Library at 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/uc
m074833.htm.  
 
CBERs web-based outreach program provides presentations about the work performed by the 
CBER offices.  A listing of available presentations can be found at 
https://www.fda.gov/BiologicsBloodVaccines/InternationalActivities/ucm273267.htm.   
 
6.  FDA Labeling and Approvals 
 
CDERs Drugs@FDA database contains information about FDA-approved brand name and 
generic prescription and nonprescription human drugs and the biological therapeutic products 
regulated by CDER.  It includes most of the approvals since 1939 and the majority of patient 
information, labels, approval letters, reviews, and other information for drug products approved 
since 1998.  The database can be used to view approval history and find all drugs with a specific 
active ingredient, consumer information, therapeutically equivalent drugs for an innovator or 
generic, generic drugs for an innovator, and labels for approved drugs.  The database can be 
found at https://www.accessdata.fda.gov/scripts/cder/daf. 
 
CBERs Biologics Products & Establishments web page contains searchable information and 
supporting documents for approved NDAs regulated by CBER, licensed biological products 
(except for therapeutic biological products regulated by CDER), premarket approvals, 
humanitarian device exemptions, and cleared 510(k) submissions.  The web page also contains 
information regarding 510(k) blood establishment computer software, donor screening assays for 
infectious agents and HIV diagnostic assays, a complete list of vaccines licensed for 
immunization and distribution in the United States, and reports including the User Fee Billable 
Biologic Products and Potencies Approved Under Section 351 of the PHS Act report.  This web 
page can be found at https://www.fda.gov/BiologicsBloodVaccines/ucm121134.htm.  
 
The FDA Online Label Repository is a searchable list of licensed products and establishments; it 
contains the most recent drug listing information companies have submitted to FDA.  The 
repository can be found at https://labels.fda.gov/. 
 
The FDA New Pediatric Labeling Information Database is a searchable list that highlights key 
pediatric information from the studies submitted in response to pediatric legislative initiatives.  
For information on new pediatric information that has been added to product labeling since 
September 9, 2007, see 
https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=labelingdatabase.   
 
23  Contains Nonbinding Recommendations 
7.  FDA Rules and Regulations 
 
FDA publishes regulations and other notices in the Federal Register, the Federal Governments 
official publication for notifying the public of many kinds of agency actions.  The FDA Rules 
and Regulations web page contains information about the notice and comment rulemaking 
process, the review of proposed and final rules, and related resources.  See 
https://www.fda.gov/RegulatoryInformation/RulesRegulations/default.htm.   
 
8.  FDA-Funded Scientific Research Results 
 
FDA publishes the results of FDA-funded scientific research.  The broad availability of scientific 
information and underlying data allow for the critical review, replication, and verification of 
findings that are central to the scientific method.  Making research findings and the digital data 
supporting those findings accessible and analyzable promotes robust and open communication 
with the scientific community thereby bolstering the credibility of scientific findings and the 
regulatory decision-making based upon those findings.  See 
https://www.fda.gov/ScienceResearch/AboutScienceResearchatFDA/ucm433459.htm.  
 
9.  Code of Federal Regulations 
 
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules 
published in the Federal Register by the departments and agencies of the Federal government.  
Final rules are integrated into the CFR by the Office of the Federal Register and Government 
Publishing Office staff.  Regulations under 21 CFR part 312 contain the procedures and 
requirements governing the use of investigational new drugs, including procedures and 
requirements for the submission to, and review by, FDA of INDs.35  These are done on a yearly 
basis.  See https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR. 
 
The Electronic Code of Federal Regulations (e-CFR) is an unofficial editorial compilation of 
CFR material and Federal Register amendments.  It is not an official legal edition of the CFR.  
The Office of the Federal Register updates the material in the e-CFR on a daily basis.  Generally, 
the e-CFR is current within 2 business days.  See http://www.ecfr.gov.   
 
 
VIII.  ADDITIONAL CONTACTS  
 
As stated in section IV., Scope of Interactions Between the Sponsor and the Review Team, the 
review division RPM is the primary point of contact between sponsors and FDA during drug 
development.  Reviewers, team leaders, and senior management generally should not be 
contacted directly.  However, in certain limited circumstances, sponsors can directly contact 
other FDA RPMs (see examples in section IV) or FDA staff who:  
 
  Serve as resources in specific functional areas (e.g., product quality, pediatrics, orphan 
drugs or rare diseases, combination products, GCP, import/export, product jurisdiction, 
                                                 
35 21 CFR 312.1 
24  Contains Nonbinding Recommendations 
biosimilar development) for the purposes of obtaining direct answers to simple 
regulatory, procedural, or administrative questions related to those functional areas  
 
  Serve as an alternative means to obtain general information (e.g., CDERs DDI, Small 
Business and Industry Assistance (SBIA), and ECT; CBERs MATTB; CDER or CBER 
Ombudsman)  
 
  Address issues that arise in the context of the regulatory process (e.g., ombudsmen)  
 
Inquiries sent to any of the specific functional areas or general contacts identified herein should 
not include questions that are integral to an existing or planned drug development plan (e.g., 
questions concerning clinical trial design, amount of data needed to support future phases of 
development or approval, nonclinical study requirements).  Those types of questions should 
always be directed to the appropriate FDA RPM, typically the review division RPM, because 
those questions are best answered by review staff who have properly considered the question 
within the context of the sponsors overall development plan, as well as having vetted their 
advice with appropriate review team members and documented the advice or decisions rendered 
to the sponsor.  By using these additional contacts and resources appropriately, sponsors may 
receive timely and comprehensive responses to basic or procedural questions in these functional 
areas that they can apply in parallel with the scientific, technical, and regulatory advice they 
receive directly from the review division RPMs during the course of their drug development 
programs.  Basic or procedural drug development questions not tied to an existing or planned 
development program (e.g., IND exemptions, expanded access, adverse event reporting, FDA 
forms) can be directed to DDI/MATTB if not identified separately here.  
 
When a sponsor chooses to contact one of these resources via email, the review division RPM 
should be copied on the email when the questions and subsequent responses may have bearing 
on review division activities or communications related to the question(s) at hand.  Similarly, 
when one of the FDA resources is responding directly to a sponsor question, the appropriate 
FDA RPM, when known and when appropriate, should be copied.  This ensures that the FDA 
RPM, and therefore review team members, are aware of pertinent information or advice 
conveyed to sponsors.  When contacting an ombudsman, the sponsor can request that the 
ombudsman consider its communications confidential; therefore, the FDA RPM may or may not 
be copied on inquiries and responses between these two parties. 
 
A.  CDER 
 
1.  Biomarker Qualification Program 
 
The Biomarker Qualification Program encourages biomarker development by providing a 
framework for development and regulatory acceptance. 
 
Contact information can be found on the Biomarker Qualification Program web page at 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualification
Program/BiomarkerQualificationProgram/ucm20086360.htm.  
 
25  Contains Nonbinding Recommendations 
2.  Controlled Substance Staff 
 
The Controlled Substance Staff (CSS) promotes the public health through the medical science-
based assessment of the abuse potential of investigative and marketed drugs.  CSS accomplishes 
this by providing consultation services to CDER review divisions as FDAs experts in the area of 
drug abuse and dependence and also serving as liaisons to the Drug Enforcement Administration 
for FDAs role in the drug scheduling process under the Controlled Substances Act.  CSS 
responds to inquiries about the drug scheduling process and the study of abuse potential in 
animal and human studies. 
 
See the Controlled Substance Staff web page at 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/uc
m180753.htm.  
 
3.  Division of Drug Information 
 
The DDI responds to a broad variety of public inquiries.  It is staffed with a team of pharmacists 
and other health professionals who provide expert advice and guidance regarding all aspects of 
CDER activities to U.S. and international consumers, health care professionals, insurance 
companies, regulated industry, academia, law enforcement, FDA, and other government 
agencies.  
 
The DDI can be contacted for responses to questions not related to a specific development 
program in a functional area that is not already listed within this section (e.g., FDA forms, 
adverse event reporting, IND exemptions). 
 
Contact information can be found on the CDER Division of Drug Information web page at 
https://www.fda.gov/aboutDDI.  
 
4.  Division of Pediatric and Maternal Health 
 
The Division of Pediatric and Maternal Health (DPMH) oversees quality initiatives that promote 
and necessitate the study of drug and biological products in the pediatric population, and 
improve pregnancy- and lactation-related information in product labeling.  DPMH collaborates 
with stakeholders both inside and outside FDA to facilitate the collection of clinically relevant, 
evidence-based information that advances the informed use of medicines in children and women 
of childbearing potential. 
 
Pediatric email:  pedsdrugs@fda.hhs.gov  
Maternal health email:  cder.pmhs@fda.hhs.gov  
 
5.  Emerging Technology Team 
 
The Emerging Technology Team (ETT), located in OPQ, is a centralized group for external 
inquiries on novel product design and manufacturing technologies likely to improve product 
safety, identity, strength, quality, and purity.  It supports innovation by providing a forum for 
26  Contains Nonbinding Recommendations 
sponsors to engage FDA early in development and ensures consistency, continuity, and 
predictability in review and inspection.  ETT also evaluates existing guidance, policy, and 
practice and helps sponsors identify and develop strategies to address potential challenges with 
respect to developing and implementing novel technologies. 
 
Contact information can be found on the Emerging Technology Program web page at 
https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm52322
8.htm. 
 
6.  Enhanced Communication Team 
 
The ECT is composed of individuals in the Office of New Drugs (OND) who are experienced 
and knowledgeable about the drug review process, interact regularly with review division staff, 
and are skilled in facilitating communications between sponsors and FDA staff.  ECT is a point 
of contact for general questions about the drug development process or for clarification on which 
OND review division to contact with questions.  ECT is also a secondary point of 
communication for sponsors who are encountering challenges in communicating with the review 
teams for their INDs.  When sponsors encounter such challenges, ECT facilitates eliciting review 
division responses to sponsor questions as described in section VI., General Expectations for 
Timing of Communications.  
 
In addition to the tasks described above, ECT is responsible for identifying and disseminating 
best practices for enhanced communication to CDER staff involved in the review of INDs.  Also, 
in collaboration with CDERs training staff, ECT develops and provides training programs for 
both CDER staff and sponsors on best practices for communication. 
 
Contact information can be found on the Enhanced Communication web page at 
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm327281.htm.  
  
7.  Import/Export 
 
The Import Export Compliance Branch serves as the coordinator for human drug import and 
export compliance issues. 
 
Contact information for general import compliance questions and export certificate and 
compliance questions can be found on the Import Export Compliance Branch (IECB) web page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ImportsandExportsCom
pliance/default.htm.   
 
8.  Office of Pharmaceutical Quality 
 
OPQ is dedicated to ensuring product quality.  OPQs work provides a uniform drug quality 
program with oversight across all manufacturing sites, whether domestic or foreign, and across 
all drug product areas  new drugs, biologics, biosimilars, generic drugs, and nonprescription 
drugs.  
 
27  Contains Nonbinding Recommendations 
OPQs RBPMs are located in the Office of Program and Regulatory Operations.  RBPMs are the 
central point of contact for inquiries related to product quality.  Application-specific inquiries 
related to product quality should be directed to the responsible RBPM; if not known, sponsors 
should contact CDER-OPQ-Inquiries@fda.hhs.gov. 
 
Additional information can be found on the Office of Pharmaceutical Quality web page at 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/uc
m418347.htm.  
 
9.  Ombudsman 
 
The CDER Ombudsman serves as a point of contact for informal advice or referrals and also 
provides an alternative means to address issues that arise in the context of the regulatory process.  
The Ombudsman receives questions and investigates complaints from regulated industry, law 
firms, and consultants, and informally resolves disputes between those entities and CDER.  
These disputes can be of a regulatory, scientific, or administrative nature. 
 
In addition, the Ombudsman can assist with resolution of scientific differences of opinion among 
staff.  The Ombudsman performs these duties while adhering to the ombudsman principles of 
confidentiality, neutrality, and informality.  Every effort is made to respond to all complaints in a 
timely and effective manner.  Upon request, communication with the Ombudsman will be 
considered confidential.  
 
Contact information can be found on the CDER Ombudsman web page at 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/Co
ntactCDER/CDEROmbudsman/default.htm.   
 
10.  Rare Diseases Program 
 
The Rare Diseases Program (RDP) facilitates, supports, and accelerates the development of 
CDER-regulated drug and biological products for the benefit of patients and families affected by 
rare disorders.  The RDP coordinates development of CDER policy, procedures, and training 
related to rare disease drug development to promote consistency and innovation in review.  
Through collaborative work with external and internal rare disease stakeholders, RDP promotes 
evidence-based science as the basis for rare disease drug development.  RDP is CDERs focal 
point to the rare disease drug development community for effective interactions with CDER. 
 
Contact information can be found on the Rare Diseases Program web page at 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/uc
m221248.htm.   
 
11.  Small Business and Industry Assistance Program 
 
The SBIA Program promotes productive interaction with regulated industry by providing timely 
and accurate information relating to development and regulation of human drug products 
28  Contains Nonbinding Recommendations 
primarily to domestic and international small businesses; however, such assistance is available to 
everyone. 
 
Contact information can be found on the CDER Small Business & Industry Assistance (SBIA) 
web page at 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/default.htm.  
 
12.  Therapeutic Biologics and Biosimilars Staff 
 
The Therapeutic Biologics and Biosimilars Staff (TBBS) is responsible for ensuring consistency 
in the scientific and regulatory approach and advice to sponsors regarding development programs 
for proposed biosimilar products and related issues regarding development programs for 
therapeutic biologics. 
 
Contact information can be found through the Industry Information and Guidance link on the 
Biosimilars web page at https://www.fda.gov/biosimilars. 
 
B.  CBER 
 
1.  Manufacturers Assistance and Technical Training Branch 
 
The MATTB provides assistance and training to industry, including large and small 
manufacturers and trade associations, and responds to general information requests for 
information received via email and telephone regarding CBER policies and procedures. 
 
Assistance is available in numerous areas including clinical investigator information, adverse 
event reporting procedures, electronic submissions guidance and requirements, and information 
on how to submit an IND to administer an investigational product to humans. 
 
Contact information can be found on the Manufacturers Assistance (CBER) web page at 
https://www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/manufacturingquestio
ns/default.htm. 
 
2.  Ombudsman 
 
The CBER Ombudsman provides an alternative means to obtain information or address issues 
that arise in the context of the regulatory process.  The Ombudsman receives questions and 
investigates complaints from regulated industry, law firms, and consultants, and works 
informally to resolve disputes between those entities and CBER.  The Ombudsman may be 
engaged by the regulated industry to address issues of a regulatory, scientific, or administrative 
nature.  In addition, the Ombudsman can assist with resolution of scientific differences of 
opinion among staff within FDA.  The Ombudsman performs these duties while adhering to the 
ombudsman principles of confidentiality, neutrality, and informality.  Every effort is made to 
respond to all complaints in a timely and effective manner.  Upon request, communication with 
the Ombudsman will be considered confidential. 
 
29  Contains Nonbinding Recommendations 
The CBER Ombudsman serves as a point of contact for informal advice or referrals, including 
product jurisdiction information, and also manages the administrative process for formal dispute 
resolution requests.  
 
Contact information can be found on the CBER Ombudsman web page at 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/uc
m122881.htm.   
 
C.  Office of Special Medical Programs 
 
The Office of Special Medical Programs (OSMP) serves as the FDA focal point for special 
programs and initiatives that are cross-cutting and clinical, scientific, and/or regulatory in nature.  
OSMP oversees and provides executive leadership to five program area offices and is comprised 
of the following:  (1) Advisory Committee Oversight and Management Staff; (2) Office of 
Combination Products; (3) Office of Good Clinical Practice; (4) Office of Orphan Products 
Development; and (5) Office of Pediatric Therapeutics.   
 
Contact information can be found on the Office of Special Medical Programs web page at 
https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/officeofscience
andhealthcoordination/default.htm.  
 
The following sections describe the five OSMP offices in further detail. 
 
1.  Advisory Committee Oversight and Management Staff 
 
The Advisory Committee Oversight and Management Staff (ACOMS) works in close 
collaboration with all FDA centers to provide consistent operations and seek continuous 
improvements in the FDA advisory committee program.  ACOMS ensures that all FDA 
committee management activities are consistent with the provisions of the Federal Advisory 
Committee Act, departmental policies, and related regulations and statutes.  ACOMS provides 
guidance and assistance on the establishment, staffing, and management of public advisory 
committees to obtain the best possible expert scientific advice to assist FDA in meeting its public 
health mission.  
 
Contact information can be found on the Advisory Committees web page at 
https://www.fda.gov/AdvisoryCommittees/default.htm.  
 
2.  Office of Combination Products 
 
The Office of Combination Products (OCP) oversees the regulatory life cycle of combination 
products and serves as the focal point for resolving combination product issues.  A combination 
product is a product composed of any combination of a drug and a device; a biological product 
and a device; a drug and a biological product; or a drug, device, and a biological product.36  OCP 
ensures the prompt assignment of combination products to FDA centers, the timely and effective 
premarketing review of such applications, and consistent and appropriate postmarketing 
                                                 
36 21 CFR 3.2(e) 
30  Contains Nonbinding Recommendations 
regulation of these products.  When a products classification and/or assignment is unclear or in 
dispute, OCP is also responsible for classifying the product as a drug, medical device, biological 
product, or combination product.  OCP assigns the product to the appropriate FDA center or, in 
the case of a combination product, assigns it to the FDA center that will have primary 
responsibility for its regulation.  In addition, OCP develops guidances and regulations to foster 
greater clarity, efficiency, and effectiveness of the regulatory process for combination products.  
OCP routinely provides responses to requests for assistance from regulated industry and FDA 
staff relating to premarketing review and postmarketing regulation of combination products.   
 
Contact information can be found on the Office of Combination Products web page at 
https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/officeofscience
andhealthcoordination/ucm2018184.htm.  
 
3.  Office of Good Clinical Practice 
 
The Office of Good Clinical Practice (OGCP) is the focal point within FDA for HSP and GCP 
issues arising in clinical trials regulated by FDA.  OGCP develops FDA-wide HSP and GCP 
policy for informed consent, institutional review boards, and clinical trial conduct; advises FDA 
staff and the research community on HSP and GCP issues; and coordinates FDAs Bioresearch 
Monitoring program, working with FDAs product centers and the Office of Regulatory Affairs.  
OGCP develops and conducts training and outreach programs, both internally and externally.  
 
Contact information can be found on the Office of Good Clinical Practice web page at 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofS
cienceandHealthCoordination/ucm2018191.htm.   
 
4.  Office of Orphan Products Development 
 
The Office of Orphan Products Development (OOPD) advances the evaluation and development 
of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the 
diagnosis and/or treatment of rare diseases or conditions that affect fewer than 200,000 people in 
the United States, or that affect more than 200,000 people when the sponsor is not expected to 
recover the costs of developing and marketing a new drug.  OOPD administers the orphan drug 
program that provides incentives for sponsors to develop products for rare diseases.  It works on 
rare disease issues with the medical and research communities, professional organizations, 
academia, governmental agencies, industry, and rare disease patient groups.  OOPD regularly 
participates in meetings with these stakeholders who seek input on orphan drug designation 
requests, humanitarian use device designation requests, rare pediatric disease designation 
requests, funding opportunities through the Orphan Products Grants Program and the Pediatric 
Device Consortium Grants Program, and other orphan product patient-related issues. 
 
Contact information can be found on the Developing Products for Rare Diseases & Conditions 
web page at 
https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm.   
 
31  Contains Nonbinding Recommendations 
5.  Office of Pediatric Therapeutics 
 
The Office of Pediatric Therapeutics works to ensure timely access to medical products proven 
to be safe and effective for children.  It is comprised of four distinct yet interrelated programs:  
scientific activities, ethics, safety, and international activities.  The Office of Pediatric 
Therapeutics provides consultative services in ethics and neonatology, coordinates the monthly 
international Pediatric Cluster, administers the congressionally mandated postmarketing safety 
reviews for pediatric products, and provides scientific data and reports on pediatric product 
development activities. 
 
Contact information can be found on the Pediatrics web page at 
https://www.fda.gov/ScienceResearch/SpecialTopics/PediatricTherapeuticsResearch/default.htm.  
 
32  Contains Nonbinding Recommendations 
REFERENCES 
 
Related Guidances37 
 
Draft guidance for industry Investigational New Drug Applications Prepared and Submitted by 
Sponsor-Investigators38 
 
Guidance for industry Advancement of Emerging Technology Applications for Pharmaceutical 
Innovation and Modernization 
 
Guidance for industry Expedited Programs for Serious Conditions  Drugs and Biologics 
 
Guidance for industry Formal Meetings Between the FDA and Biosimilar Biological Product 
Sponsors or Applicants 
 
Guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of 
PDUFA Products 
 
Guidance for industry IND Meetings for Human Drugs and Biologics; Chemistry, 
Manufacturing, and Controls Information 
 
Guidance for industry Providing Regulatory Submissions in Electronic Format  Certain 
Human Pharmaceutical Product Applications and Related Submissions Using the eCTD 
Specifications 
 
Guidance for industry Providing Regulatory Submissions in Electronic Format  Submissions 
Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act 
 
Guidance for review staff and industry Good Review Management Principles and Practices for 
PDUFA Products 
 
Related CDER MAPPs39 
 
MAPP 4515.1 Email Best Practices 
 
MAPP 6025.1 Good Review Practices 
 
                                                 
37 Guidances can be found on the FDA Drugs guidance web page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
 
38 When final, this guidance will represent the FDAs current thinking on this topic. 
 
39 MAPPs can be found on the Manual of Policies and Procedures web page at 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoli 
ciesProcedures/default.htm. 
 
33  Contains Nonbinding Recommendations 
MAPP 6025.6 Good Review Practice:  Management of Breakthrough Therapy-Designated 
Drugs and Biologics 
 
MAPP 6030.9 Good Review Practice:  Good Review Management Principles and Practices for 
Effective IND Development and Review 
 
Related CBER SOPPs40 
 
SOPP 8101.1 Regulatory Meetings With Sponsors and Applicants for Drugs and Biological 
Products  
 
SOPP 8104 Documentation of Telephone Contacts With Regulated Industry 
 
SOPP 8113 Handling of Regulatory Faxes in CBER 
 
SOPP 8119 Use of Email for Regulatory Communications 
 
SOPP 8212 Management of Breakthrough Therapy-Designated Products:  Sponsor Interactions 
and Status Assessment Including Rescinding 
 
                                                 
40 SOPPS can be found on the Biologics Procedures (SOPPs) web page at 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/defau
lt.htm. 
34