Formal Meetings 
Between FDA and 
ANDA Applicants of 
Complex Products 
Under GDUFA 
Guidance for Industry 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
October 2022 
Generic Drugs 
 
Revision 1 
   
Formal Meetings 
Between FDA and 
ANDA Applicants of 
Complex Products 
Under GDUFA 
Guidance for Industry 
 
 
 
 
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/guidance-compliance-regulatory-information/guidances-drugs  
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
October 2022 
Generic Drugs 
 
Revision 1 
 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  MEETING TYPES ........................................................................................................... 4 
  A.    Product Development Meetings ............................................................................................ 4 
  B.    Pre-Submission Meetings ....................................................................................................... 5 
  C.    Mid-Cycle Review Meetings and Enhanced Mid-Cycle Review Meetings ........................ 6 
  D.    Post-CRL Scientific Meetings ............................................................................................... 8 
IV.  GDUFA III PERFORMANCE GOALS ......................................................................... 9 
  A.    Performance Goals for Product Development Meetings .................................................... 9 
  B.    Performance Goals for Pre-Submission Meetings ............................................................... 9 
  C.    Performance Goals for MCRMs and EMCRMs ................................................................. 9 
  D.    Performance Goals for Post-CRL Scientific Meetings ...................................................... 10 
V.  MEETING REQUESTS ................................................................................................. 10 
  A.    Product Development and Pre-Submission Meetings ....................................................... 10 
  B.    MCRMs and EMCRMs ....................................................................................................... 11 
  C.    Post-CRL Scientific Meetings .............................................................................................. 12 
VI.  EVALUATING MEETING REQUESTS ..................................................................... 12 
  A.    Meeting Request Denied ...................................................................................................... 12 
  B.    Meeting Request Granted .................................................................................................... 13 
VII.  RESCHEDULING AND CANCELING MEETINGS ................................................ 13 
  A.    Rescheduled Meetings .......................................................................................................... 13 
  B.    Canceled Meetings ................................................................................................................ 14 
VIII.  MEETING PACKAGE CONTENT AND SUBMISSION .......................................... 16 
  A.    Timing of Submission ........................................................................................................... 16 
  B.    Where and How Many Copies of Meeting Packages to Send ........................................... 16 
  C.    Meeting Package Content .................................................................................................... 16 
IX.  PRE-MEETING COMMUNICATIONS WITH APPLICANTS ............................... 23 
X.  PROCEDURES FOR CONDUCT OF MEETINGS ................................................... 24 
  A.    Introductions and Agenda ................................................................................................... 24 
  B.    End of Meeting Summary .................................................................................................... 24 
  C.    Presentations ......................................................................................................................... 25 
  Contains Nonbinding Recommendations 
XI.  DOCUMENTATION AND MEETING MINUTES .................................................... 25 
XII.  RESOLUTION OF DISPUTE ABOUT MEETING MINUTES ................................ 25 
XIII.   APPENDICES ................................................................................................................. 27 
A.     SUMMARY OF SCOPE AND CRITERIA FOR MEETINGS  .............................      
FOR COMPLEX PRODUCTS UNDER GDUFA III .......................................... 27 
B.    PRE-SUBMISSION MEETING PRESENTATION  ...............................................   
OUTLINE TEMPLATE FOR PROSPECTIVE ANDA APPLICANTS ........... 30 
  Contains Nonbinding Recommendations 
Formal Meetings Between FDA and ANDA Applicants of Complex 
Products Under GDUFA 
Guidance for Industry1 
 
 
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  
 
This guidance describes an enhanced pathway for discussions between FDA and a prospective 
applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated 
new drug application (ANDA) for a complex product, as defined in this guidance.  Specifically, 
this guidance provides information on requesting and conducting product development meetings, 
pre-submission meetings, mid-cycle review meetings (MCRMs),2 enhanced mid-cycle review 
meetings (EMCRMs), and post-complete response letter (CRL) scientific meetings with FDA.  
 
This guidance reflects a unified approach to formal meetings between FDA and prospective 
ANDA applicants or ANDA applicants for complex products under the pre-ANDA program and 
the ANDA assessment program.3,4,5  This guidance will assist applicants in generating and 
submitting to FDA a meeting request and the associated meeting package for complex products, 
 
1 This guidance has been prepared by the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and 
Research (CDER) at the Food and Drug Administration. You may submit comments on this guidance at any time.  
Submit comments to Docket No. FDA-2017-D-5739 (available at https://www.regulations.gov/docket?D=FDA-
2017-D-5739).   
2 The name of this meeting has been changed in the GDUFA Reauthorization Performance Goals and Program 
Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter) to mid-cycle review meeting from mid-
review cycle meeting in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 
2018-2022 (GDUFA II commitment letter).  The GDUFA III commitment letter is available at 
https://www.fda.gov/media/153631/download and the GDUFA II commitment letter is available at 
https://www.fda.gov/media/101052/download. 
3 For purposes of this guidance, a formal meeting includes any meeting that is requested by a prospective ANDA 
applicant or ANDA applicant following the request procedures provided in this guidance, as well as any mee,ing 
offered by the Agency following the procedures in this guidance, and includes meetings conducted in any format 
(e.g., teleconference, videoconference, face-to-face, written responses only).   
4 Applicant is defined as any person who submits an...ANDA...under this part to obtain FDA approval of a new 
drug and any person who owns an approved...ANDA.  21 CFR 314.3(b).  This guidance uses the term ANDA 
applicant when discussing meetings that occur after an ANDA is received (i.e., MCRM, EMCRM, and post-CRL 
scientific meeting), the term prospective ANDA applicant when discussing meetings that occur before an ANDA is 
received (i.e., the product development and pre-submission meetings), and the term applicants when referring to 
both prospective ANDA applicants and ANDA applicants.   
5 GDUFA III commitment letter at 21-29. 
  1  Contains Nonbinding Recommendations 
as defined in this guidance, that are or will be the subject of ANDAs submitted under section 
505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C 355(j)), and as 
contemplated in the GDUFA Reauthorization Performance Goals and Program Enhancements 
Fiscal Years 2023-2027 (GDUFA III commitment letter).6 
 
This guidance revises the guidance of the same title issued in November 2020.  This revision is 
being issued to incorporate information on the complex product meeting types and performance 
goals included in the GDUFA III commitment letter, including information on requesting these 
meetings and FDAs procedures for handling these meetings.    
 
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 guidance means that something is suggested or recommended, but 
not required.   
 
 
II.  BACKGROUND 
 
The Generic Drug User Fee Amendments of 2012 (GDUFA I)7 amended the FD&C Act to 
authorize FDA to assess and collect user fees to provide the Agency with resources8 to help 
ensure patients have access to quality, affordable, safe, and effective generic drugs.  GDUFA fee 
resources bring greater predictability and timeliness to the review of generic drug applications.  
GDUFA has been reauthorized every 5 years to continue FDAs ability to assess and collect 
GDUFA fees, and this user fee program has been reauthorized two times since GDUFA I, most 
recently in the Generic Drug User Fee Amendments of 2022.  As described in the GDUFA III 
commitment letter applicable to this latest reauthorization, FDA has agreed to performance goals 
and program enhancements regarding aspects of the generic drug assessment program that build 
on previous authorizations of GDUFA.  New enhancements to the program are designed to 
maximize the efficiency and utility of each assessment cycle, with the intent of reducing the 
number of assessment cycles for ANDAs and facilitating timely access to generic medicines for 
American patients. 
 
As described in the GDUFA III commitment letter, the pre-ANDA program includes product 
development meetings and pre-submission meetings and is intended to clarify regulatory 
expectations for prospective ANDA applicants early in product development, assist applicants in 
developing more complete submissions, promote a more efficient and effective ANDA 
assessment process, and reduce the number of assessment cycles required to obtain ANDA 
approval.9  The ANDA assessment meeting program for complex products includes MCRMs, 
 
6 See footnote 2.  
7 Title III of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144. 
8 User fees are available for obligation in accordance with appropriations acts.  
9 GDUFA III commitment letter at 21. The pre-ANDA program includes additional enhancements other than 
meetings, such as product-specific guidances, that are outside the scope of this guidance.   
  2  Contains Nonbinding Recommendations 
EMCRMs, and post-CRL scientific meetings.10  The ANDA assessment meeting program is 
intended to provide or continue to provide targeted, robust advice to ANDA applicants as they 
work to meet the standards for ANDA approval.  Some elements of these programs are tailored 
to enhance the development of complex generic products.11 
 
As defined in the GDUFA III commitment letter, complex products generally include: 
 
1.  Products with complex active ingredients (e.g., peptides, polymeric 
compounds, complex mixtures of [active pharmaceutical ingredients], 
naturally sourced ingredients); complex formulations (e.g., liposomes, 
colloids); complex routes of delivery (e.g., locally acting drugs such as 
dermatological products, complex ophthalmological products, and otic dosage 
forms that are formulated as suspensions, emulsions or gels) or complex 
dosage forms (e.g., transdermal systems, metered dose inhalers, extended-
release injectables); 
 
2.  Complex drug-device combination products (e.g., pre-filled auto-injector 
products, metered dose inhalers); and  
 
3.  Other products where complexity or uncertainty concerning the approval 
pathway or possible alternative approach would benefit from early scientific 
engagement.12 
 
To facilitate development of complex products that may be submitted in an ANDA, FDA and 
industry agreed to different types of meetings between applicants and FDA to discuss the 
proposed complex product and support submission of a high-quality, approvable ANDA, as well 
as to provide or continue to provide targeted, robust advice as applicants work to meet the 
standards for ANDA approval.13,14 
 
 
 
10 GDUFA III commitment letter at 27-29.  In addition to these meetings for complex products, other meetings 
described in the GDUFA III commitment letter are available for both complex and non-complex products, including 
post-CRL clarification teleconferences, product-specific guidance teleconferences, pre-submission product-specific 
guidance meetings, and post-submission product-specific guidance meetings.  For more information on these 
meetings, see the guidance for industry Post-Complete Response Clarification Between FDA and ANDA Applicants 
Under GDUFA (October 2022) and the GDUFA III commitment letter at 24-25.  For the most recent version of a 
guidance, check the FDA Drugs guidance web page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
11 GDUFA III commitment letter at 27. 
12 GDUFA III commitment letter at 45-46.  See also CDERs Manual of Policies and Procedures (MAPP) 5240.10 
Classifying Approved New Drug Products and Drug-device Combination Products as Complex Products for 
Generic Drug Development Purposes, available at https://www.fda.gov/media/157675/download.    
13 Although only prospective ANDA applicants and ANDA applicants can request meetings under the pre-ANDA 
and ANDA Assessment Meeting programs (GDUFA III commitment letter at 21, 27), an applicant may include 
other relevant entities in the meeting, e.g., consultants or drug master file holders. 
14 FDA has received, responded to, and granted certain meeting requests for products that do not fit within the 
definition of a complex product as defined in the GDUFA III commitment letter and as used in this guidance.  
Meeting requests for products that do not fit within the scope of this guidance will be granted based on the workload 
and availability of staff and the anticipated value to the ANDA assessment process. 
  3  Contains Nonbinding Recommendations 
III.  MEETING TYPES 
 
A.  Product Development Meetings 
 
Product development meetings for complex products that may be submitted in an ANDA provide 
a forum for a scientific exchange on specific issues (e.g., a proposed study design, alternative 
approach, additional study expectations, or questions), in which FDA agreed to provide targeted 
advice regarding an ongoing ANDA development program.15  To engage in a substantive 
discussion, FDA expects that the prospective ANDA applicant has enough knowledge of the 
complex product to allow FDA to provide appropriate feedback that will advance product 
development early in the process (e.g., the prospective ANDA applicant has generated its own 
data to be discussed).  FDA recommends that the prospective ANDA applicant submit no more 
than one request for a product development meeting for the specific complex product per year, 
but FDA anticipates that some prospective ANDA applicants of complex products may request 
more than one product development meeting.  If, following a product development meeting, a 
prospective ANDA applicant is seeking further clarification or has new questions related to what 
was discussed at the meeting, we recommend that the applicant submit such a request, with any 
new information or data, in a controlled correspondence for FDAs review.16  If the prospective 
ANDA applicant has new information, data, or questions for Agency input that will not be 
adequately addressed in a controlled correspondence, the prospective ANDA applicant can 
request an additional product development meeting.  The Agency will determine whether to 
grant the subsequent product development meeting based on the content of the meeting request 
and meeting package and available resources.  
 
The GDUFA III commitment letter identifies when a product development meeting will and 
when a product development meeting may be granted.17   
 
A product development meeting will be granted if, in FDAs judgment:  
 
1.  The requested meeting concerns (1) development of a complex generic product for which 
FDA has not issued a product-specific guidance, or (2) an alternative equivalence 
evaluation (i.e., change in study type, such as in vitro to clinical) for a complex product 
for which FDA has issued a product-specific guidance; 
 
2.  FDA determines the prospective ANDA applicants meeting package is complete, 
including any data generated and specific proposals for product development (e.g., details 
regarding the proposed product development plan, such as an alternative study design, 
and sufficient justification to support the proposal), as applicable;  
 
3.  A controlled correspondence response would not adequately address the prospective 
ANDA applicants questions; and  
 
 
15 GDUFA III commitment letter at 25. 
16 See the guidance for industry Controlled Correspondence Related to Generic Drug Development (December 
2020). 
17 GDUFA III commitment letter at 25-26. 
  4  Contains Nonbinding Recommendations 
4.  A product development meeting would significantly improve ANDA assessment 
efficiency (e.g., ultimately decrease the number of review cycles for the application).18      
 
FDA may grant a product development meeting, dependent on available resources, if, in FDAs 
judgment:  
 
1.  The requested meeting concerns complex development issues other than those identified 
above (e.g., FDA has developed a product-specific guidance and the prospective ANDA 
applicant is not proposing an alternative equivalence evaluation); 
 
2.  FDA determines the prospective ANDA applicants meeting package is complete, 
including any data generated and specific proposals for product development (e.g., details 
regarding the proposed product development plan, such as an alternative study design, 
and sufficient justification to support the proposal), as applicable;  
 
3.  A controlled correspondence response would not adequately address the prospective 
ANDA applicants questions; and  
 
4.  A product development meeting would significantly improve ANDA assessment 
efficiency (e.g., ultimately decrease the number of review cycles for the application).19 
 
FDA can meet the product development meeting goal by either conducting a meeting or 
providing a meaningful written response that will inform drug development and/or regulatory 
decision-making to the prospective ANDA applicant, within the applicable goal date.20   
 
B.  Pre-Submission Meetings 
 
Prospective ANDA applicants of complex products may request a pre-submission meeting.  The 
purpose of a pre-submission meeting is to provide a prospective ANDA applicant the 
opportunity to present unique or novel data or information that will be included in the ANDA 
submission such as formulation, key studies, justifications, and/or methods used in product 
development, as well as the interrelationship of the data and information in the ANDA.21   
 
The pre-submission meeting does not include substantive assessment of summary data or full 
study reports, but FDA will identify items or information that should be clarified before 
submission of the ANDA.  The pre-submission meeting is not an opportunity to determine 
whether the application is acceptable for receipt.22   
 
 
18 GDUFA III commitment letter at 25.  
19 GDUFA III commitment letter at 26. 
20 Ibid.   
21 Ibid.  In general, a prospective ANDA applicant should not submit questions in a pre-submission meeting request.  
If a prospective ANDA applicant has questions related to its ANDA development program, those questions should 
be submitted in a product development meeting request.   
22 For example, the prospective ANDA applicant should not request or expect guidance on whether certain 
components needed for receipt consideration may be omitted from the ANDA. 
  5  Contains Nonbinding Recommendations 
FDA anticipates that the pre-submission meeting request will be submitted approximately 6 to 8 
months before submission of the ANDA.  FDA attendees at the pre-submission meeting will 
generally include staff that attended the product development meeting, if held, and ANDA 
assessment team members that may assess the ANDA once received. 
 
FDA recommends that a prospective ANDA applicant of a complex product seek FDAs input 
via a product development meeting prior to submitting a request for a pre-submission meeting so 
that FDA has knowledge of the prospective ANDA applicants development program at the time 
of the pre-submission meeting.23  Prospective ANDA applicants, however, can request a pre-
submission meeting whether or not they had a product development meeting.  FDA agreed to 
grant a pre-submission meeting if the prospective ANDA applicant was granted a product 
development meeting for the same complex generic product or FDA believes in its sole 
discretion that the pre-submission meeting would improve assessment efficiency.24,25    
 
C.  Mid-Cycle Review Meetings and Enhanced Mid-Cycle Review Meetings 
 
During the first assessment cycle, an ANDA applicant for a complex product that was granted a 
prior product development meeting for the same complex product may request either an MCRM 
or an EMCRM.26,27,28  The request should be submitted within 7 days29 of receiving the last mid-
cycle discipline review letter (DRL) (i.e., the latter of the quality DRL and the bioequivalence or 
clinical bioequivalence DRL).30  For example, if the bioequivalence or clinical bioequivalence 
DRL is received on November 1, 2022, and the quality DRL is received on November 14, 2022, 
 
23 A prospective ANDA applicant that had a product development meeting or received written responses only from 
FDA is not obligated to request a pre-submission meeting.   
24 See GDUFA III commitment letter at 26.  FDA can meet the product development meeting goal by either 
conducting a meeting or providing a written response.  See also section IV.A of this guidance. 
25 See GDUFA commitment letter at 26.  FDA may also grant pre-submission meetings for a prospective ANDA 
applicant of a non-complex product if FDA decides the pre-submission meeting would improve ANDA assessment 
efficiency and dependent on available resources.  In general, pre-submission meeting requests for non-complex 
products will be denied.   
26 See GDUFA commitment letter at 27.  Such ANDA applicants will be notified in the ANDA Filing 
Acknowledgment letter that they are eligible to request an MCRM or EMCRM.        
27 ANDA applicants of complex products that have participated only in a pre-submission meeting may be eligible to 
request an MCRM or EMCRM during the first assessment cycle at Agency discretion and will be notified in the 
ANDA Filing Acknowledgement letter if they are eligible to request an MCRM or EMCRM. 
28 ANDA applicants for a drug product designated as a competitive generic therapy (CGT) may be eligible to 
request an MCRM during the first assessment cycle.  ANDA applicants for a complex drug product designated as a 
CGT may be eligible to request an EMCRM during the first assessment cycle.  FDA will notify an ANDA applicant 
for a drug designated as a CGT of its eligibility to request an MCRM or EMCRM in the ANDA Filing 
Acknowledgement letter or the CGT Designation Grant letter.  For more information on MCRMs and EMCRMs for 
applications for drug products designated as CGT, see the guidance for industry Competitive Generic Therapies 
(October 2022).   
29 See the GDUFA III Commitment Letter at 47, stating that [d]ays  unless otherwise specified, means calendar 
days. 
30 GDUFA III commitment letter at 27.  Mid-cycle DRLs include two separate letters addressing quality potential 
deficiencies and bioequivalence potential deficiencies.  Applicants eligible for MCRMs or EMCRMs should submit 
a meeting request within 7 days of receiving the latter of the two DRLs.  If an applicant requests an MCRM or an 
EMCRM more than 7 days after receiving the latter of the DRLs or prior to receiving the last DRL, the request will 
be denied. 
  6  Contains Nonbinding Recommendations 
the applicant should submit the request for an MCRM or an EMCRM within 7 days of 
November 14, 2022.   
 
The MCRM provides the ANDA applicant an opportunity to ask for the rationale for any 
deficiency identified in the mid-cycle DRL(s), and/or to ask questions related to FDAs 
assessment of the data or information in the ANDA.31  An ANDA applicant cannot present any 
new data or information at this meeting.32   
 
The EMCRM provides the ANDA applicant an opportunity to ask questions related to a 
proposed scientific path to address possible deficiencies identified in the mid-cycle DRL(s).33  
An applicant may ask questions about potential new data or information to address any possible 
deficiencies identified in the mid-cycle DRL(s).34  FDA will discuss the data and information but 
will not provide substantive assessment of the data or information provided by the ANDA 
applicant at the meeting.35   
 
An ANDA applicant should not respond to a DRL prior to the MCRM or EMCRM if the ANDA 
applicant intends to ask questions regarding that DRL in an MCRM or EMCRM.  If the response 
due date for a DRL is before the date by which an ANDA applicant must request the MCRM or 
EMCRM, an ANDA applicant should request an extension to respond to that DRL.  If an ANDA 
applicant responds to a DRL prior to the MCRM or EMCRM, FDA will deny an MCRM or 
EMCRM request for the questions related to that DRL or will cancel the MCRM or EMCRM.     
 
FDA will only grant one request in the first assessment cycle (i.e., an MCRM or an EMCRM, 
not both) subject to the criteria described above.  FDA recommends that an ANDA applicant 
request an EMCRM when the ANDA applicant has questions that are within the scope of both an 
MCRM and an EMCRM.  Requests for MCRMs that contain questions that are within the scope 
of both an MCRM and an EMCRM may be granted an MCRM for the questions that are within 
the scope of an MCRM and will receive a denial for the questions within the scope of an 
EMCRM.  
 
If an ANDA applicant requests and FDA grants an MCRM, FDA will extend the response due 
date for the relevant DRL(s), with the response due 15 days after the date of the MCRM.   
 
If an ANDA applicant requests and FDA grants an EMCRM, FDA will extend the ANDA goal 
date by 60 days (i.e., FDA will add 60 days to the goal date).36  FDA also will extend the 
response due date for the relevant DRL(s).  FDA will recalculate the response due date starting 
from the date of the meeting and will extend the response due date by the number of days that 
were included for a response in the DRL.37  For example, if the response was due 30 days after 
the DRL was issued, the response will be due 30 days after the date of the EMCRM. 
 
31 GDUFA III commitment letter at 27-28.  
32 Ibid at 28. 
33 Ibid.   
34 Ibid.  
35 Ibid.   
36 Ibid.  
37 Ibid. 
  7  Contains Nonbinding Recommendations 
 
An applicant may submit an Unsolicited Amendment after an EMCRM, which could result in an 
additional goal date extension, as described in section I(C) of the GDUFA III commitment 
letter.38 
 
In addition, an applicants response to a DRL (regardless of whether the applicant had an MCRM 
or EMCRM) may result in an additional goal date extension.39 
 
D.  Post-CRL Scientific Meetings 
 
ANDA applicants can request post-CRL scientific meetings for FDA to provide scientific advice 
on possible approaches to address deficiencies identified in a CRL related to establishing 
equivalence.40  ANDA applicants can request a post-CRL scientific meeting even if they have 
not had a product development meeting.  FDA agreed to grant the meeting if it is for a complex 
generic product or in FDAs judgment the request raises issues that are best addressed via this 
meeting process and cannot be adequately addressed through controlled correspondence.41  An 
ANDA applicant may have a post-CRL teleconference to seek clarification concerning 
deficiencies identified in a CRL (post-CRL clarification teleconference) prior to requesting this 
meeting.42    
 
An ANDA applicants post-CRL scientific meeting request must discuss one or more of the 
following as it relates to establishing equivalence: 
 
1.  New equivalence study needed to address the deficiencies in the design identified in the 
CRL; 
2.  Approach that is different from that submitted in the ANDA, e.g., a change in study type 
from in vivo to in vitro; 
3.  New comparative use human factors study; or 
4.  New approach to demonstrating sameness of a complex active ingredient.43 
 
In a post-CRL scientific meeting request, an ANDA applicant can submit questions both within 
the scope described above as well as clarifying questions.  In contrast, a post-CRL clarification 
teleconference is limited to clarifying questions.  ANDA applicants that have only clarifying 
questions, therefore, should consider requesting a post-CRL clarification teleconference within 
10 days of the issuance of the CRL.44  
 
 
38 Ibid at 10.  In general, an unsolicited amendment submitted prior to the meeting will not be discussed during the 
EMCRM (or MCRM) because the unsolicited amendment is not included in the meeting package.     
39 See the guidance for industry Information Requests and Discipline Review Letters Under GDUFA (October 
2022).  See also the GDUFA III commitment letter at 13.    
40 GDUFA III commitment letter at 28.  
41 Ibid. at 29. 
42 Ibid. at 29, 16. See also the guidance for industry Post-Complete Response Letter Clarification Teleconferences 
Between FDA and ANDA Applicants Under GDUFA (October 2022). 
43 GDUFA III commitment letter at 28-29. 
44 See the guidance for industry Post-Complete Response Letter Clarification Teleconferences Between FDA and 
ANDA Applicants Under GDUFA (October 2022).  
  8  Contains Nonbinding Recommendations 
 
IV.  GDUFA III PERFORMANCE GOALS 
 
As reflected in the GDUFA III commitment letter, FDA committed to meet certain performance 
goals associated with the pre-ANDA and ANDA assessment meetings for complex products 
described in this guidance.45  The goals described below in subsections A, B, and D only apply 
to meetings related to complex products under GDUFA III (i.e., requests submitted on or after 
October 1, 2022, and subject to the criteria described in this guidance).  The goals described 
below in subsection C only apply to ANDAs found acceptable for filing on or after October 1, 
2022, and subject to the criteria described in this guidance.46  
 
A.  Performance Goals for Product Development Meetings 
 
FDA agreed to grant or deny 90 percent of product development meeting requests within 14 days 
after receipt of the meeting request.  If granted, FDA agreed to conduct 90 percent of product 
development meetings within 120 days after the meeting is granted.47  
 
FDA can also meet the product development meeting goal by providing a meaningful written 
response to the prospective ANDA applicant, within the applicable goal date, that will inform 
drug development and/or regulatory decision-making.48 
 
B.  Performance Goals for Pre-Submission Meetings 
 
FDA agreed to grant or deny 90 percent of pre-submission meeting requests within 30 days.  If 
granted, FDA agreed to conduct 90 percent of pre-submission meetings within 60 days of the 
meeting request.49  
 
C.  Performance Goals for MCRMs and EMCRMs 
 
If an MCRM is requested and granted, the meeting will take place within 30 days after the date 
the ANDA applicant submits the meeting request.  If an EMCRM is requested and granted, the 
meeting will take place within 90 days after issuance of the last mid-cycle DRL (i.e., the latter of 
the quality DRL and the bioequivalence or clinical bioequivalence DRL).50   
 
 
45 Consistent with FDAs other user fee programs, FDA will calculate the goal date from the day after a submission.  
GDUFA III commitment letter at 4.  Please also refer to FDAs guidance for industry Providing Regulatory 
Submissions in Electronic Format  Receipt Dates (February 2014) for information on how FDA calculates receipt 
dates for regulatory submissions in electronic format.  As described in that guidance, requests will be received by 
the Agency Monday through Friday from 12:00 a.m. to 11:59 p.m. Eastern Standard Time/Eastern Daylight Time, 
excluding Federal holidays and days when the FDA office that will review the request is closed. 
46 For ANDAs found acceptable for filing during GDUFA II and that are eligible for a mid-review cycle meeting 
under the GDUFA II commitment letter, FDA will initiate scheduling the meeting.  See the GDUFA II Commitment 
Letter.     
47 GDUFA III commitment letter at 26.   
48 Ibid.   
49 Ibid at 27.  
50 Ibid at 28.   
  9  Contains Nonbinding Recommendations 
D.  Performance Goals for Post-CRL Scientific Meetings 
 
FDA agreed to grant or deny the post-CRL scientific meeting request within 14 days after receipt 
of the request.51  If granted, FDA agreed to hold the post-CRL scientific meeting within 90 days 
after the date the meeting is granted.52   
 
 
V.  MEETING REQUESTS  
 
A request for a product development meeting, pre-submission meeting, MCRM, EMCRM, or 
post-CRL scientific meeting should be submitted electronically, as explained below in this 
section.   
 
If FDA determines that the request does not contain the information specified in this section, the 
request will not be considered to be submitted for purposes of GDUFA III performance goals. 
 
A.  Product Development and Pre-Submission Meetings 
 
A request for a product development or pre-submission meeting for complex products that may 
be submitted in an ANDA should be sent electronically through the CDER Direct NextGen 
Collaboration Portal.53  A request for a pre-submission meeting should clearly indicate whether 
the prospective ANDA applicant had a product development meeting with FDA.  If no product 
development meeting was held, the prospective ANDA applicant should explain why a pre-
submission meeting should be granted.  A product development or pre-submission meeting 
request should include the following information:  
 
1.  Pre-assigned ANDA number.54 
2.  Meeting type being requested (i.e., product development or pre-submission). 
 
3.  Reference listed drug (RLD) and its application number. 
 
4.  Established Name. 
 
5.  Dosage form, route of administration, and strength. 
 
6.  A statement indicating whether the submission is being made by the prospective ANDA 
applicant or by a U.S. agent on behalf of the prospective ANDA applicant. 
 
51 Ibid at 29. 
52 Ibid. 
53 The CDER Direct NextGen Collaboration Portal may be accessed at 
https://edm.fda.gov/EDMIDPLogin/welcome?response_type=code&client_id=0oa1as7rb2poiYTch297&scope=ope
nid%20profile&state=1802935594_1580919665259&redirect_uri=https%3A%2F%2Fedm.fda.gov%2Foidcclient%
2Fedmrp.  
54 See information regarding requesting a pre-assigned application number available on FDAs website at 
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/uc
m114027.htm. 
  10  Contains Nonbinding Recommendations 
 
7.  Contact person for the meeting (i.e., the person submitting the meeting request), with 
their title and affiliation, secure email address,55 and phone number.  This is the person 
with whom FDA will communicate about the meeting. 
 
8.  The meeting package (see section VIII of this guidance), which should be submitted at 
the time of the meeting request for both product development and pre-submission 
meetings. 
 
B.  MCRMs and EMCRMs 
 
A request for an MCRM or EMCRM should be submitted to the ANDA via the Electronic 
Submissions Gateway (ESG) within 7 calendar days of receiving the latter of the quality DRL 
and the bioequivalence or clinical bioequivalence DRL.56  The cover page should identify the 
submission as a Mid-Cycle Review Meeting Request or Enhanced Mid-Cycle Review 
Meeting Request.  ANDA applicants should also e-mail a copy of the cover page that was 
submitted via the ESG to the Regulatory Project Manager.     
 
An MCRM request should include the following information: 
 
1.  The specific deficiency(ies) that the ANDA applicant is requesting the rationale for 
and/or the questions related to FDAs assessment of the data or information in the 
ANDA. 
 
2.  The meeting package (see section VIII of this guidance), which should be submitted at 
the time of the request for the MCRM. 
 
An EMCRM request should include the following information: 
 
1.  If applicable, the specific deficiency(ies) that the ANDA applicant is requesting the 
rationale for and/or the questions related to FDAs assessment of the data or information 
in the ANDA.  
 
2.  Questions related to a proposed scientific path to address possible deficiencies identified 
in the mid-cycle DRL(s) and any questions about potential new data or information to 
address possible deficiencies identified in the mid-cycle DRL(s).     
 
3.  The meeting package (see section VIII of this guidance), which should be submitted at 
the time of the request for the EMCRM. 
 
 
55 Secure email between CDER and ANDA applicants and prospective ANDA applicants is useful for informal 
communications when confidential information (e.g., trade secrets or patient information) may be included in the 
message.  Secure email should not be used for formal regulatory submissions.  For more information on establishing 
a secure email link with CDER, please contact SecureEmail@fda.hhs.gov.  
56 See footnote 30.    
  11  Contains Nonbinding Recommendations 
C.  Post-CRL Scientific Meetings 
 
A request for a post-CRL scientific meeting should be submitted to the ANDA via the ESG.  The 
cover page should identify the submission as a Post-Complete Response Letter Scientific 
Meeting Request.  A complete post-CRL scientific meeting request package should include the 
following information: 
 
1.  The specific approaches to address deficiencies identified in the CRL related to 
establishing equivalence, grouped by discipline.  An applicants post-CRL scientific 
meeting request must discuss one or more of the following as it relates to establishing 
equivalence, and the meeting request should identify which one(s) the applicant wants to 
discuss: (1) a new equivalence study needed to address the deficiencies in the design 
identified in the CRL, (2) an approach that is different from that submitted in the ANDA, 
e.g., a change in study type from in vivo to in vitro, (3) a new comparative use human 
factors study, or (4) a new approach to demonstrating sameness of a complex active 
ingredient.57 
 
2.  The meeting package (see section VIII of this guidance), which should be submitted at 
the time of the request for the post-CRL scientific meeting. 
 
 
VI.  EVALUATING MEETING REQUESTS  
 
FDA will determine whether to grant a product development meeting request, pre-submission 
meeting request, MCRM or EMCRM request, or post-CRL scientific meeting request for 
complex products, and a response will be provided to the applicant by granting or denying the 
meeting request pursuant to the performance goals stated in the GDUFA III commitment letter 
(see section IV of this guidance) and as described below.  Although applicants can request a 
particular format, FDA evaluates each meeting request and determines whether or not the request 
should be granted, the final meeting type, and the appropriate format.   
 
A.     Meeting Request Denied 
 
If a meeting request is denied, written notification to the applicant will include an explanation of 
the reason for the denial.   
 
Denials of meeting requests submitted in conformity with the GDUFA III performance goals will 
be based on a substantive reason, not merely on the absence of a minor element of the meeting 
request or meeting package items.  For example:    
 
  A product development or pre-submission meeting request may be denied because the 
product does not meet the criteria for a complex product as provided in section II of this 
guidance or because a meeting is premature for the stage of product development in light 
of the insufficiency of the data generated.   
 
 
57  GDUFA III commitment letter at 28-29. 
  12  Contains Nonbinding Recommendations 
  An MCRM request or EMCRM request may be denied if the applicant did not participate 
in a prior product development meeting or pre-submission meeting or the product does 
not meet the criteria for a complex product as provided in section II of this guidance.  In 
addition, the request will be denied if the request is made before issuance of the last mid-
cycle DRL or the request is made more than 7 days after the issuance of the last mid-
cycle DRL.        
 
  A post-CRL scientific meeting request may be denied because the product does not meet 
the criteria for a complex product as provided in section II of this guidance, in FDAs 
judgment the request raises issues that can be adequately addressed through controlled 
correspondence, or the meeting request does not discuss one of the following as it relates 
to establishing equivalence: 
  a new equivalence study needed to address the deficiencies in the design identified in 
o
the CRL, 
  an approach that is different from that submitted in the ANDA, e.g., a change in study 
o
type from in vivo to in vitro, 
  a new comparative use human factors study, or 
o
  a new approach to demonstrating sameness of a complex active ingredient.58 
o
 
If a meeting request is denied, a subsequent request to schedule a meeting will be considered as a 
new request (i.e., a request that is assigned a new set of time frames as described in section IV of 
this guidance). 
 
B.     Meeting Request Granted 
 
If a request for a meeting is granted, FDA will provide written notification to the applicant of the 
decision.  FDA may indicate that the request is granted in part for the questions that are 
appropriate for the meeting type requested and denied in part for the questions that are not 
appropriate for the meeting type requested.  If FDA will be providing a written response only 
instead of holding a meeting or teleconference, FDA will advise the applicant that a written 
response only is forthcoming.  If FDA plans to hold a meeting or teleconference, FDA will 
schedule the meeting or teleconference by determining the date, time, length, format, and 
expected FDA participants.  All of the scheduling information will be forwarded to the applicant 
either with the notification granting the meeting or teleconference or as soon as possible 
following notification that the request has been granted, and the meeting or teleconference will 
be scheduled within the specified GDUFA III performance goals (see section IV of this 
guidance).         
 
 
VII.  RESCHEDULING AND CANCELING MEETINGS 
 
A.  Rescheduled Meetings  
 
Occasionally, circumstances may arise that necessitate the rescheduling of a meeting.  If a 
meeting needs to be rescheduled, FDA will work to reschedule it as soon as possible after the 
 
58 GDUFA III commitment letter at 28-29. 
  13  Contains Nonbinding Recommendations 
original date.  A new meeting request should not be submitted.  Applicants and FDA should take 
reasonable steps to avoid rescheduling meetings.  For example, if an attendee becomes 
unavailable, a substitute can be identified, or comments on the topic that the attendee would have 
addressed can be forwarded to the applicant following the meeting.  It will be at FDAs 
discretion whether the meeting should be rescheduled depending on the specific circumstances.   
 
A meeting may be rescheduled by FDA if, for example:  
 
1.  The assessment team determines that additional information is needed from the applicant 
to address the applicants questions. 
 
2.  Essential attendees are no longer available for the scheduled date and time because of an 
emergency. 
 
3.  Attendance by additional FDA offices not originally anticipated or requested by the 
applicant is critical and the offices availability precludes holding the meeting on the 
original date. 
 
4.  There is a regulatory policy issue that is yet to be resolved that may affect the response to 
the applicants questions. 
 
5.  The Federal Government is closed or opening is delayed due to inclement weather, 
emergency, or other reason. 
 
If an applicant requests that a meeting be rescheduled, FDA will evaluate the request and it will 
be at FDAs discretion whether to grant the request to reschedule.  FDA will try to ensure a 
rescheduled meeting occurs within the goal date (see section IV of this guidance).59  If FDA, in 
its discretion, decides to reschedule the meeting and is unable to reschedule it within the original 
goal date, FDA will notify the applicant of the reason for the rescheduled date, and FDA will still 
consider the performance goal met if the Agency is able to schedule and conduct the meeting 
within 30 days of the original goal date. 
 
B.  Canceled Meetings 
 
Occasionally, circumstances may arise that necessitate the canceling of a meeting.  If a meeting 
is canceled, a subsequent request to schedule a meeting will be considered a new request. 
Applicants and FDA should take reasonable steps to avoid canceling meetings (unless the 
meeting is no longer necessary).  It will be at FDAs discretion whether the meeting should be 
canceled depending on the specific circumstances.   
 
A product development meeting may be canceled if, for example: 
 
1.  The prospective ANDA applicant withdraws the meeting request, 
 
59 FDA does not recommend that applicants request to reschedule MCRMs or EMCRMs due to the timeframe for 
conducting these meetings (see section IV.C) and because these meetings are conducted during the assessment 
cycle.   
  14  Contains Nonbinding Recommendations 
 
2.  The prospective ANDA applicant informs FDA that its questions have been adequately 
answered by the preliminary written comments, or 
 
3.  FDA issues product-specific guidance on establishing bioequivalence to the RLD that is 
the basis of submission for the prospective ANDA applicant and which addresses the 
questions in the meeting package.60  
 
If a prospective ANDA applicant requests to cancel a product development meeting after 
preliminary responses are issued, FDA will count the performance goal as met.  If FDA cancels 
the meeting on its own initiative, the meeting request will not be counted for performance goal 
purposes.   
 
A pre-submission meeting may be canceled if, for example: 
  
1.  the prospective ANDA applicant withdraws the meeting request, or 
 
2.  the applicant submits the ANDA.   
 
An MCRM may be canceled if, for example:  
 
1.  The ANDA applicant withdraws the meeting request, or 
 
2.  The ANDA applicant submits a response to the DRL(s) that the questions in the meeting 
package are based on.  
 
An EMCRM may be canceled if, for example:  
 
1.  The ANDA applicant withdraws the meeting request,  
 
2.  The ANDA applicant informs FDA that its questions have been adequately answered by 
preliminary written comments, or 
 
3.  The ANDA applicant submits a response to the DRL(s) that the questions in the meeting 
package are based on.  
 
If an ANDA applicant requests to cancel an EMCRM after the goal date has been extended, the 
extended goal date will remain.  
 
A post-CRL scientific meeting may be canceled if, for example:  
 
1.  The ANDA applicant withdraws the meeting request,  
 
60 FDA publishes new and revised product-specific guidances describing the Agencys current recommendations for 
demonstrating bioequivalence and certain other approval requirements.  Please check for the availability of new and 
revised product-specific guidances in the Federal Register and on the FDA website at the following address:  
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm.  
  15  Contains Nonbinding Recommendations 
 
2.  The ANDA applicant informs FDA that its questions have been adequately answered by 
the preliminary written comments, or  
 
3.  The applicant submits a response to the CRL.     
  
 
VIII.  MEETING PACKAGE CONTENT AND SUBMISSION 
 
Pre-meeting preparation is critical for achieving a productive discussion or exchange of 
information at meetings for complex products that may be submitted or have been submitted in 
an ANDA.  Preparing the meeting package should help the applicant focus on describing its 
principal areas of interest.  The meeting package should provide information relevant to the 
discussion topics and enable FDA to prepare adequately for the meeting.  The meeting package 
should clearly indicate the type of meeting the applicant is requesting and should include 
adequate information for FDA to assess the potential utility of the meeting and to identify the 
appropriate staff that should attend the meeting.   
 
A.  Timing of Submission 
 
The meeting package should be submitted to FDA so that it is received concurrently with the 
meeting request. 
 
B.  Where and How Many Copies of Meeting Packages to Send 
 
Both the product development and pre-submission meeting packages should be submitted 
electronically to the CDER Direct NextGen Collaboration Portal at the same time as the meeting 
request.   
 
The MCRM, EMCRM, and post-CRL scientific meeting packages should be submitted to the 
ANDA via the ESG at the same time as the meeting request.   
 
It is not necessary to submit any paper copies of the meeting package. 
 
C.  Meeting Package Content 
  
The meeting package should provide information relevant to the product, development stage, and 
meeting type requested, in addition to any supplementary information needed to help FDA 
develop responses to issues raised by the applicant.  The meeting package should contain 
sufficient detail to meet the intended meeting objectives. 
 
To facilitate FDA review, the meeting package content should be organized according to the 
proposed agenda.  The meeting package should be a sequentially paginated document (individual 
sections can be numbered separately, as long as there is an overall pagination covering the whole 
submission) with a table of contents, appropriate indices, appendices, cross-references, and tabs 
differentiating sections.   
  16  Contains Nonbinding Recommendations 
 
1.  General Meeting Package Content 
 
Meeting packages for each of the meeting types included in this guidance generally should 
include the following information: 
 
1.  Pre-assigned ANDA number or ANDA number. 
 
2.  Established name. 
 
3.  RLD and application number. 
 
4.  A brief statement of the purpose and objectives of the meeting.  This statement should 
include a brief background of the issues underlying the agenda.  
 
2.  Product Development Meetings 
 
For product development meetings, in addition to the information in subsection 1  General 
Meeting Package Content, meeting packages should generally also include:  
 
1.  Chemical structure. 
 
2.  Dosage form, route of administration, and dosing regimen (frequency and duration). 
 
3.  Proposed indications (e.g., prospective ANDA applicant is not seeking approval for 
all of the RLDs indications).   
 
4.  A brief statement indicating how the product meets the criteria for a complex product 
(see section II).  
 
5.  A background section that includes the following: 
 
  A brief history of the development program. 
 
  The status of product development. 
 
 
 
 
  17  Contains Nonbinding Recommendations 
6.  The requested format61  face-to-face,62 videoconference,63 teleconference,64 or 
written response only.65  For requested formats other than written response only, the 
meeting request package should also include the following information: 
 
  A proposed agenda and discussion topics, outlining how the 60-minute time frame 
allotted for the product development meeting should be apportioned for 
discussing each agenda item.     
 
  Suggested dates and times (e.g., morning or afternoon) for the meeting that are 
within the time frame for a product development meeting.  Nonavailability dates 
and times should also be included. 
 
  A list of all individuals, with their titles and affiliations, who will participate in 
the requested meeting from the applicants organization, including consultants 
and interpreters.66  
 
7.  A list of questions for discussion, grouped by discipline, as applicable, with each 
question clearly numbered (e.g., 1, 2, 3 without subquestions).  For each question, 
there should be a brief explanation of the context and purpose of the question and any 
supporting rationale or data, as applicable.  The prospective ANDA applicant should 
consider the duration of the proposed meeting when determining the proposed 
questions. The package should be organized such that following a summary list of all 
questions, each question is followed by the corresponding supporting justification, 
rationale, or data, as applicable, followed by the next question. 
 
8.  Data to support discussion organized by discipline and question.  The level of detail 
should be appropriate to the meeting type requested and the product development 
stage (e.g., if an approach or alternative approach is proposed for establishing 
equivalence, sufficient rationale together with at least preliminary data should be 
provided). 
 
 
 
61 For prospective ANDA applicants that meet the criteria in the GDUFA III commitment letter for a product 
development meeting, FDA will generally grant the prospective ANDA applicants requested format.  If FDA, in its 
discretion, provides the opportunity for a product development meeting to a prospective ANDA applicant that does 
not meet the criteria in the GDUFA III commitment letter, FDA has the discretion to select the format.    
62 Face-to-face meetings are those in which the majority of attendees participate in person at the FDA.   
63 Videoconferences are meetings in which the attendees participate from various remote locations via a video 
connection. 
64 Teleconference means a verbal communication by telephone, and not a written response, unless otherwise agreed 
to by the applicant.  GDUFA III commitment letter at 48.    
65 Written response only responses are sent in lieu of a meeting or teleconference when requested by or otherwise 
agreed to by the applicant.   
66 The applicant should notify their FDA point of contact (POC) immediately if the list of meeting participants from 
the applicants organization and consultants changes.  In this situation, FDA may reschedule the meeting if the 
revised list of meeting participants requires additional FDA personnel.  In the event this meeting is ultimately 
rescheduled outside the 120-day window, FDA will consider the GDUFA III goal of conducting the meeting within 
120 days of granting the meeting request met.     
  18  Contains Nonbinding Recommendations 
3.  Pre-Submission Meetings 
 
For pre-submission meetings, in addition to the information in subsection 1  General Meeting 
Package Content, meeting packages should generally also include:67 
 
1.  Chemical structure. 
 
2.  Dosage form, route of administration, and dosing regimen (frequency and duration). 
 
3.  Proposed indications (e.g., prospective ANDA applicant is not seeking approval for 
all of the RLDs indications).   
 
4.  A brief statement indicating how the product meets the criteria for a complex product 
(see section II).  
 
5.  A background section that includes the following: 
 
  A brief history of the development program. 
 
  The status of product development. 
 
6.  The requested format68  face-to-face or videoconference.  The meeting request 
package should also include the following information: 
 
  A proposed agenda and discussion topics, outlining how the 60-minute time frame 
allotted for the pre-submission meeting should be apportioned for discussing each 
agenda item.  
 
  Suggested dates and times (e.g., morning or afternoon) for the meeting that are 
within the time frame for a pre-submission meeting.  Nonavailability dates and 
times should also be included. 
 
 
67 In general, high-level information is sufficient for the pre-submission meeting package.  The meeting package can 
be in the format of a draft meeting presentation.  For a suggested pre-submission meeting presentation outline 
template with recommendations on information that should be included, see Appendix B of this guidance.  If the 
meeting request is granted, the draft presentation may be updated up to 21 days prior to the meeting date so that 
FDA may provide preliminary comments on the presentation 5 days before the meeting.  The final presentation 
should be sent to the FDA no later than 48 hours before the meeting.  
68 For prospective ANDA applicants that meet the criteria in the GDUFA III commitment letter for a pre-submission 
meeting, FDA will generally grant the prospective ANDA applicants requested format.  If FDA, in its discretion, 
provides the opportunity for a pre-submission meeting to a prospective ANDA applicant that does not meet the 
criteria in the GDUFA III commitment letter, FDA has the discretion to select the format.  Due to the nature of the 
pre-submission meeting, teleconference and written response only are not options for this meeting type.    
  19  Contains Nonbinding Recommendations 
  A list of all individuals, with their titles and affiliations, who will participate in 
the requested meeting from the applicants organization, including consultants 
and interpreters.69  
 
7.  Whether the prospective applicant had a product development meeting with FDA.  If 
no product development meeting was held, the prospective applicant should explain 
why a pre-submission meeting should be granted.  
 
8.  The event IDs for previously granted product development meeting(s). 
 
9.  A summary of the advice provided at the product development meeting(s). 
 
10. The estimated timeline for when the prospective ANDA applicant plans to submit its 
ANDA.70 
 
11. Unique or novel data or information that will be included in the ANDA submission, 
such as formulation, key studies, justifications, and/or methods used in product 
development, as well as the interrelationship of the data and information in the 
ANDA. 
 
4.  MCRMs 
 
For MCRMs, in addition to the information in subsection 1  General Meeting Package Content, 
meeting packages should generally also include: 
 
1.  The specific deficiency(ies) that the applicant is requesting the rationale for and/or the 
questions related to FDAs assessment of the data or information in the ANDA.   
 
2.  The requested format71  teleconference or written response only.  For requested 
teleconferences, the request package should also include the following information: 
 
  A proposed agenda outlining how the 30-minute time frame allotted for the 
MCRM should be apportioned for discussing each agenda item.   
   
 
69 The applicant should notify their FDA POC immediately if the list of meeting participants from the applicants 
organization and consultants changes.  In this situation, FDA may reschedule the meeting if the revised list of 
meeting participants requires additional FDA personnel.  In the event this meeting is ultimately rescheduled outside 
the 60-day window, FDA will consider the GDUFA III goal of conducting the meeting within 60 days of granting 
the meeting request met.     
70 FDA recommends that a prospective ANDA applicant submits its pre-submission meeting request approximately 
6 to 8 months before submission of the ANDA.  
71 For applicants that meet the criteria in the GDUFA III commitment letter for an MCRM, FDA will generally grant 
the ANDA applicants requested format.  If FDA, in its discretion, provides the opportunity for an MCRM to an 
ANDA applicant that does not meet the criteria in the GDUFA III commitment letter, FDA has the discretion to 
provide a written response only instead of a teleconference.    
  20  Contains Nonbinding Recommendations 
  Suggested dates and times (e.g., morning or afternoon) for the teleconference that 
are within the time frame of an MCRM.  Nonavailability dates and times should 
also be included. 
 
  A list of all individuals, with their titles and affiliations, who will participate in 
the requested meeting from the applicants organization, including consultants 
and interpreters.72  
 
  A list of specific assessment disciplines asked to participate in the requested 
teleconference based on the questions to be discussed.  FDA has discretion to 
determine which assessment disciplines attend the teleconference.  FDA will have 
appropriate staff participate in the teleconference to respond to the applicants 
questions, which may be from different disciplines than the disciplines that the 
applicant requested to participate.           
 
5.  EMCRMs 
 
For EMCRMs, in addition to the information in subsection 1  General Meeting Package 
Content, meeting packages should generally also include: 
 
1.  If applicable, the specific deficiency(ies) that the applicant is requesting the rationale 
for and/or the questions related to FDAs assessment of the data or information in the 
ANDA.   
 
2.  Questions related to a proposed scientific path to address possible deficiencies 
identified in the mid-cycle DRL(s) and any questions about potential new data or 
information to address possible deficiencies identified in the mid-cycle DRL(s).73   
 
3.  The requested format74  face-to-face, video conference, teleconference, or written 
response only.  For requested formats other than written response only, the meeting 
request package should also include the following information: 
 
  A proposed agenda outlining how the 60-minute time frame allotted for the 
EMCRM should be apportioned for discussing each agenda item.     
 
 
72 The applicant should notify their FDA POC immediately if the list of participants from the applicants 
organization and consultants changes.  In this situation, FDA may reschedule the teleconference if the revised list of 
teleconference participants requires additional FDA personnel.  In the event this teleconference is ultimately 
rescheduled outside the 30-day window, FDA will consider the GDUFA III goal of conducting the teleconference 
within 30 days of the date the applicant submits the request met.     
73 As stated in section III.B of this guidance, FDA will not provide substantive assessment of the data or information 
provided by the applicant at the meeting.  
74 For applicants that meet the criteria in the GDUFA III commitment letter for an EMCRM, FDA will generally 
grant the applicants requested meeting format.  If FDA, in its discretion, provides the opportunity for an EMCRM 
to an ANDA applicant that does not meet the criteria in the GDUFA III commitment letter, FDA has the discretion 
to provide a teleconference or written response only instead of a meeting.    
  21  Contains Nonbinding Recommendations 
  Suggested dates and times (e.g., morning or afternoon) for the meeting that are 
within the time frame of an EMCRM.  Nonavailability dates and times should 
also be included. 
 
  A list of all individuals, with their titles and affiliations, who will participate in 
the requested meeting from the applicants organization, including consultants 
and interpreters.75  
 
  A list of specific assessment disciplines asked to participate in the requested 
meeting or teleconference based on the questions to be discussed.  FDA has 
discretion to determine which assessment disciplines attend the meeting.  FDA 
will have appropriate staff participate in the meeting or teleconference to respond 
to the applicants questions, which may be from different disciplines than the 
disciplines that the applicant requested to participate.                  
 
6.  Post-CRL Scientific Meetings 
 
For post-CRL scientific meetings, in addition to the information in subsection 1  General 
Meeting Package Content, meeting packages should generally also include: 
 
1.  A brief statement indicating how the product meets the criteria for a complex product 
(see section II).  
 
2.  The specific approaches to address deficiencies identified in the CRL, grouped by 
discipline, with data to support discussion.  The meeting package must discuss one or 
more of the following: (1) a new equivalence study needed to address the deficiencies 
identified in the CRL; (2) an approach that is different from that submitted in the 
ANDA, e.g., a change in study type from in vivo to in vitro; (3) a new comparative 
use human factors study; or (4) a new approach to demonstrating sameness of a 
complex active ingredient.        
 
3.  The requested format76  face-to-face, videoconference, teleconference, or written 
response only.  For requested formats other than written response only, the meeting 
request package should also include the following information:  
 
 
75 The applicant should notify their FDA POC immediately if the list of meeting participants from the applicants 
organization and consultants changes.  In this situation, FDA may reschedule the meeting if the revised list of 
meeting participants requires additional FDA personnel.  In the event this meeting is ultimately rescheduled outside 
the 90-day window, FDA will consider the GDUFA III goal of conducting the meeting within 90 days after issuance 
of the last mid-cycle DRL met.     
76 For ANDA applicants that meet the criteria in the GDUFA III commitment letter for a post-CRL scientific 
meeting, FDA will generally grant the applicants requested format.  If FDA, in its discretion, provides the 
opportunity for a post-CRL scientific meeting to an ANDA applicant that does not meet the criteria in the GDUFA 
III commitment letter, FDA has the discretion to provide a teleconference or written response only instead of a 
meeting or direct the ANDA applicant to utilize the controlled correspondence pathway.    
  22  Contains Nonbinding Recommendations 
  A proposed agenda and discussion topics, outlining how the 60-minute time frame 
allotted for the post-CRL scientific meeting should be apportioned for discussing 
each agenda item.  
   
  Suggested dates and times (e.g., morning or afternoon) for the meeting that are 
within the time frame for a post-CRL scientific meeting.  Nonavailability dates 
and times should also be included. 
 
  A list of all individuals, with their titles and affiliations, who will participate in 
the requested meeting from the applicants organization, including consultants 
and interpreters.77  
 
  A list of specific assessment disciplines asked to participate in the requested 
meeting or teleconference based on the questions to be discussed.  FDA has 
discretion to determine which assessment disciplines attend the meeting.  FDA 
will have appropriate staff participate in the meeting or teleconference to respond 
to the applicants questions, which may be from different disciplines than the 
disciplines that the applicant requested to participate.                  
 
 
IX.  PRE-MEETING COMMUNICATIONS WITH APPLICANTS 
 
For a product development meeting, if FDA is not providing a written response to the 
prospective ANDA applicant, FDA agreed to provide preliminary written comments to the 
prospective ANDA applicants point of contact and FDA intends to provide such comments 5 
calendar days before the meeting.78  For a pre-submission meeting, FDA agreed to provide 
preliminary written comments to the prospective ANDA applicants point of contact 5 calendar 
days before the meeting.79 
 
In general, FDA does not intend to provide preliminary written comments in advance of an 
MCRM.  For EMCRMs, FDA intends to provide preliminary written comments to the ANDA 
applicants point of contact no later than 3 calendar days before the meeting.       
 
For post-CRL scientific meetings, FDA intends to provide preliminary written comments to the 
ANDA applicants point of contact no later than 5 calendar days before the meeting.   
 
Communications before the meeting between applicants and FDA, including preliminary written 
comments, can serve as a foundation for discussion or as the final meeting responses.  
Nevertheless, preliminary written comments should not be construed as final unless there is 
 
77 The applicant should notify their POC immediately if the list of meeting participants from the applicants 
organization and consultants changes.  In this situation, FDA may reschedule the meeting if the revised list of 
meeting participants requires additional FDA personnel.  In the event this meeting is ultimately scheduled outside 
the 90-day window, FDA will consider the GDUFA III goal of conducting the meeting within 90 days of granting 
the meeting request met.     
78 GDUFA III commitment letter at 26.  
79 Ibid. at 27. 
  23  Contains Nonbinding Recommendations 
agreement between the applicant and FDA that additional discussion is not necessary for any 
question (i.e., when the meeting is canceled because the applicant is satisfied with FDAs 
preliminary written comments), or the applicant and FDA agree a particular question is 
considered resolved, allowing extra time for discussion of other questions during the meeting.  
After receiving the preliminary written comments, the applicant should provide an updated 
agenda with its list of questions for discussion in order of priority, no later than 48 hours before 
the scheduled meeting.  Preliminary written comments communicated by FDA should not 
generate the submission of new questions, and new questions will not be entertained at the 
meeting.  
 
  
X.  PROCEDURES FOR CONDUCT OF MEETINGS 
 
A.  Introductions and Agenda 
 
Product development and pre-submission meetings for complex products will be chaired by an 
FDA staff member and will begin with introductions80 and a statement of the agenda.   
 
In general, for product development meetings, the meeting participants will discuss the questions 
posed and the data provided by the prospective ANDA applicant to assist its complex product 
development program.   
 
In general, for pre-submission meetings, the prospective ANDA applicant will present the unique 
or novel data or information that will be included in the ANDA submission.   
 
The Regulatory Project Manager assigned to the ANDA will manage the MCRM or the 
EMCRM.  In general, for MCRMs, the meeting participants will discuss the questions posed 
about the rationale for any deficiency identified in the mid-cycle DRL, and/or questions related 
to the FDAs assessment of the data or information in the ANDA.  In general, for EMCRMs, the 
meeting participants will discuss the questions related to a proposed scientific path to address 
possible deficiencies in the mid-cycle DRL(s).  
 
Post-CRL scientific meetings for complex products will be chaired by an FDA staff member and 
will begin with introductions81 and a statement of the agenda.  In general, the meeting 
participants will discuss scientific advice on possible approaches to address deficiencies 
identified in the CRL related to establishing equivalence.    
 
B.  End of Meeting Summary 
 
Before the end of the meeting, FDA attendees and the applicant attendees should summarize the 
important discussion points, agreements, clarifications, and action items.  Generally, the 
applicant will be asked to present the summary to ensure that there is mutual understanding of 
 
80 In general, FDA attendees may include, as applicable, additional staff from CDERs OGD, Office of 
Pharmaceutical Quality (OPQ), Office of Surveillance and Epidemiology, and Office of New Drugs. Center for 
Devices and Radiological Health staff may also attend if the complex product has a device component.  
81 See footnote 80.   
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meeting outcomes and action items.  FDA staff can add or further clarify any important points 
not covered in the summary, and these items can be added to the meeting minutes.  The summary 
can be done at the end of the meeting or after the discussion of each question. 
 
C.  Presentations 
 
Presentations by applicants are not generally needed for meetings, except for pre-submission 
meetings, because the information necessary for review and discussion should be part of the 
meeting package.  If an applicant plans to make a presentation, the presentation should be 
discussed ahead of time with the FDA point of contact to ensure that FDA has the presentation 
materials ahead of the meeting, if possible.  All presentations should be kept brief to maximize 
the time available for discussion. 
 
The length of the meeting will not be increased to accommodate a presentation.  If a presentation 
contains more than a small amount of content distinct from clarifications or explanations of 
previous data, or contains data that were not included in the original meeting package submitted 
to FDA for review, FDA staff may not be able to provide comments on the new information. 
 
FDA does not expect that the ANDA applicant attendees of the MCRMs will provide any 
presentations. 
 
 
XI.  DOCUMENTATION AND MEETING MINUTES 
 
Documentation of meeting outcomes, agreements and disagreements, issues for further 
discussion, and action items is critical to ensuring that this information is preserved for meeting 
attendees and for future reference.  FDA minutes are the official record of the meeting.  FDA 
agreed to issue the official, finalized minutes to the prospective ANDA applicant within 30 days 
after the product development or pre-submission meeting.82  FDA intends to issue the official, 
finalized minutes to the ANDA applicant for the MCRM, EMCRM, or post-CRL scientific 
meeting within 30 days after the meeting.  
 
 
XII.  RESOLUTION OF DISPUTE ABOUT MEETING MINUTES 
 
On occasion, there may be disputes regarding the accuracy and sufficiency of the minutes of a 
product development meeting, pre-submission meeting, MCRM, EMCRM, or post-CRL 
scientific meeting.  An applicant requesting additional clarification of the meeting minutes issued 
by FDA should contact the assigned FDA point of contact.  FDA recommends that the applicant 
submit its concerns about the meeting minutes in writing to FDA within 10 calendar days of 
receipt of the official meeting minutes.  This process addresses issues with the meeting minutes 
only.   
 
If a prospective ANDA applicant needs to discuss additional issues that were not addressed at the 
product development or pre-submission meeting, the prospective ANDA applicant should submit 
 
82 GDUFA III commitment letter at 26 and 27. 
  25  Contains Nonbinding Recommendations 
a controlled correspondence or a new meeting request.  If an ANDA applicant needs to discuss 
additional issues that were not addressed at the MCRM or EMCRM, the ANDA applicant should 
contact the Regulatory Project Manager.83  If an ANDA applicant needs to discuss additional 
issues that were not addressed at the post-CRL scientific meeting, the ANDA applicant should 
submit a controlled correspondence or a request for another post-CRL scientific meeting.      
 
If, after following up as described above, there are still significant differences in the applicants 
and FDAs understanding of the content of the official meeting minutes, the applicant should 
notify FDA in writing with respect to specific disagreements.  The applicant should submit the 
correspondence to its application or, if there is no application, submit a letter to the division 
director of the division that chaired the meeting, with a copy to the FDA point of contact 
describing the concern. 
 
The applicants concerns will be taken under consideration by the assessment division and senior 
management, if senior management was present at the meeting.  If the minutes are determined to 
accurately and sufficiently reflect the meeting discussion, the point of contact will convey this 
decision to the applicant, and the minutes will stand as the official documentation of the meeting.  
If, after discussions with the applicant, FDA deems it necessary to change the official minutes, 
the changes will be documented in an addendum to the official minutes.  The addendum will also 
document any continued objections.84   
 
83 The applicant should not submit a request for another MCRM or EMCRM.  FDA will deny such a request.    
84 Any addendum will be shared with the applicant by FDA. 
  26  Contains Nonbinding Recommendations 
XIII.   APPENDICES  
 
A.  Summary of Scope and Criteria for Meetings for Complex Products Under 
GDUFA III 
 
Meeting Type  Purpose/Scope  Criteria  Additional Considerations 
Product Development   (a) Development of a    Meets the purpose/scope   
complex product for    Prospective ANDA 
which FDA has not issued  applicant submits a 
product-specific guidance  complete meeting package 
  Controlled correspondence 
response would not 
adequately address the 
prospective applicants 
questions 
  Product development 
meeting would 
significantly improve 
ANDA assessment 
efficiency  
(b) Alternative equivalence    Meets the purpose/scope   
evaluation for a complex    Prospective ANDA 
product for which FDA  applicant submits a 
has issued a product- complete meeting package 
specific guidance    Controlled correspondence 
response would not 
adequately address the 
prospective applicants 
questions 
  Product development 
meeting would 
significantly improve 
ANDA assessment 
efficiency 
(c) Complex product    Meets the purpose/scope    Granting of meeting is 
development issues other    Prospective ANDA  dependent on available 
than those described in (a)  applicant submits a  resources 
and (b) above  complete meeting package   
  Controlled correspondence 
response would not 
adequately address the 
prospective applicants 
questions 
  Product development 
meeting would 
significantly improve 
ANDA assessment 
efficiency 
       
  27  Contains Nonbinding Recommendations 
       
       
Meeting Type  Purpose/Scope  Criteria  Additional 
Considerations 
Pre-Submission    Opportunity for    Prospective ANDA    Meeting request should be 
  prospective ANDA  applicant that was granted  submitted approximately 6 
  applicants to present  a product development  to 8 months before 
unique or novel data or  meeting for the same  submission of the ANDA 
information that will be  complex generic product     Prospective ANDA 
included in the ANDA    FDA agreed to grant a pre- applicant that was granted 
submission such as  submission meeting to a  a product development 
formulation, key studies,  prospective ANDA  meeting, had a product 
justifications, and/or  applicant of a complex  development meeting, or 
methods used in product  product that did not have a  received a written 
development, as well as  product development  response only is not 
the interrelationship of the  meeting if FDA believes  obligated to request a pre-
data and information in  in its sole discretion that  submission meeting 
the ANDA  the pre-submission 
meeting would improve 
assessment efficiency 
Mid-Cycle Review    Opportunity for the    Held during the first    MCRMs are requested by 
applicant to ask for  review cycle with ANDA  the ANDA applicant. The 
rationale for any  applicants of complex  applicant will submit a 
deficiency(ies) identified  products that were granted  meeting package and 
in the mid-cycle DRL(s),  a prior product  proposed agenda 
and/or to ask questions  development meeting for    An applicant cannot 
related to FDA's  the same product  present any new data or 
assessment of the data or    ANDA applicants of  information at this 
information in the ANDA    complex products that  meeting 
have participated only in a 
pre-submission meeting 
may be eligible to request 
an MCRM at Agency 
discretion and will be 
notified in the ANDA 
Filing Acknowledgement 
letter if they are eligible to 
request an MCRM 
  Applicants of CGT- 
designated ANDAs that 
have not had a product 
development meeting will 
be notified in either the 
ANDA Filing 
Acknowledgement letter 
or CGT Designation Grant 
letter if they are eligible to 
request an MCRM 
  28  Contains Nonbinding Recommendations 
Meeting Type  Purpose/Scope  Criteria  Additional 
Considerations 
Enhanced Mid-Cycle    Opportunity for the    Held during the first    EMCRMs are requested 
Review  ANDA applicant to ask  review cycle with ANDA  by the ANDA applicant.  
questions related to a  applicants of complex  The applicant will submit 
proposed scientific path to  products that have were  a meeting package and 
address possible  granted a prior product  agenda 
deficiencies identified in  development meeting for    FDA will discuss the data 
the mid-cycle DRL(s). An  the same product  and information but will 
applicant may ask    ANDA applicants of  not provide substantive 
questions about potential  complex products that  assessment of data or 
new data or information to  have participated only in a  information provided by 
address any possible  pre-submission meeting  the applicant at the 
deficiencies identified in  may be eligible to request  meeting 
the mid-cycle DRL(s)  an EMCRM at Agency    If an applicant requests 
discretion and will be  and FDA grants an 
notified in the ANDA  EMCRM, FDA will 
Filing Acknowledgement  extend the goal date and 
letter if they are eligible to  the response due date for 
request an EMCRM  the relevant DRL(s) as 
described on page 28 of 
the GDUFA III 
commitment letter and in 
section III.C above 
Post-CRL Scientific    Opportunity for ANDA    A complex generic    An applicant can have a 
applicants to seek  product or in FDAs  post-CRL teleconference 
scientific advice from  judgment the request  described on page 16 of 
FDA on possible  raises issues that are best  the GDUFA III 
approaches to address  addressed via this meeting  commitment letter prior to 
deficiencies identified in a  process and cannot be  requesting this meeting 
CRL related to  adequately addressed    Applicants are eligible to 
establishing equivalence  through controlled  request a post-CRL 
  correspondence  scientific meeting even if 
  An applicants post-CRL  they have not had a 
scientific meeting request  product development 
must discuss one or more  meeting 
of the four categories   
described on pages 28-29 
of the GDUFA III 
commitment letter and in 
section III.D above 
 
   
  29  Contains Nonbinding Recommendations 
B.  Pre-Submission Meeting Presentation Outline Template for Prospective ANDA 
Applicants 
 
The pre-submission meeting presentation outline template provided below is intended to assist 
prospective ANDA applicants in preparing pre-submission meeting presentations, and it includes 
suggested items from the Agency for prospective ANDA applicants to present at the pre-
submission meetings to help orient the discussion.  Suggested items for the pre-submission 
meeting presentation include, but are not limited to: (1) formulation; (2) new analytical methods; 
(3) new statistical methods; (4) novel in vitro drug release testing methods; (5) alternative 
bioequivalence study design to the recommendations in the product-specific guidance with 
justification for the alternative study design; (6) regulatory history; and (7) summary of generic 
development.      
 
Prospective ANDA applicants should address the suggested items, as applicable, and provide 
responses/information as appropriate in a concise and clear manner.    
 
Note that the information included below is not an exhaustive list of the information that 
prospective ANDA applicants should consider including in their pre-submission meeting 
presentation.  There may be additional items that should be included in the pre-submission 
meeting presentation.   
 
Presentation Outline Template: 
 
1.  Pre-Submission Meeting Request Summary 
a.  Applicant name  
b.  Anticipated ANDA submission date 
c.  Reference Listed Drug (RLD) 
i.  Information on drug substance, dosage form, route of administration 
ii.  RLD information (RLD number, approval date, application holder) 
iii.  Indication(s) 
iv.  Dose and route of administration 
d.  Reference Standard 
i.  Indicate if the Reference Standard is the same as the RLD 
ii.  When the Reference Standard is different from the RLD, include the 
Reference Standard information (application number, approval date, 
application holder) 
e.  Complex drug as defined by the GDUFA III commitment letter (indicate all that 
apply) 
i.  Complex active ingredient 
ii.  Complex formulation 
iii.  Complex route of delivery 
iv.  Complex dosage form 
v.  Complex drug-device combination 
vi.  Other complexity 
 
  30  Contains Nonbinding Recommendations 
2.  Justification for the Request (indicate all that apply)  
a.  Complex drug product 
b.  ANDA to be submitted within 6 to 8 months of pre-submission meeting request 
c.  Previous product development meeting 
d.  Other justification 
 
3.  Regulatory History 
a.  Previous communications with FDA, including but not limited to: 
i.  Controlled correspondence 
ii.  Pre-ANDA meeting requests 
iii.  Suitability petitions 
iv.  PSG teleconference 
v.  Pre-submission PSG meeting requests 
vi.  Competitive generic therapy (CGT) designation requests 
 
4.  Summary of Generic Drug Development  
a.  Provide a brief summary of the status of the generic drug product development 
program, including but not limited to: 
i.  Formulation development 
ii.  Stability 
iii.  Status of bioequivalence evaluation 
 
5.  Formulation Composition 
a.  Inactive ingredients exceeding the maximum potency per unit dose and/or 
maximum daily exposure specified in the inactive ingredient database 
i.  No 
ii.  Yes, with justification  
b.  Formulation composition assessment 
i.  Yes, per regulation (e.g., qualitative (Q1) and quantitative (Q2) sameness)  
ii.  Yes, per PSG recommendations (e.g., Q1/Q2 or no significant 
difference) 
iii.  No 
c.  Formulation composition table 
 
6.  Filing 
a.  Waiver requests, if any 
b.  Noteworthy items related to filing 
 
7.  Labeling 
a.  Unique or novel labeling differences 
b.  Labeling differences due to proposed differences in device design 
 
8.  Bioequivalence 
a.  Product-specific guidance (PSG) available 
i.  No 
ii.  Yes 
  31  Contains Nonbinding Recommendations 
b.  Deviation from recommendations in PSG 
i.  No 
ii.  Yes, with minor deviation (e.g., study design, study population, etc.) 
iii.  Yes, with major deviation (e.g., an alternative bioequivalence approach, 
different statistical analysis, etc.) 
c.  A brief description of the deviation (if applicable) 
d.  Failed bioequivalence study with the same or different test formulation 
e.  In vitro dissolution test conducted for supporting bioequivalence: 
i.  No 
ii.  Yes, to request biowaiver for additional strength(s) 
iii.  Yes, as a pivotal in vitro bioequivalence study 
f.  Novel bioanalytical methods used in the in vivo bioequivalence study or novel 
analytical methods used for in vitro bioequivalence study with justification  
g.  Novel statistical analysis used for supporting bioequivalence with justification 
h.  Other novel scientific approaches with justification 
 
9.  User Interface Assessment (if applicable) 
a.  FDA recommends that applicants use and follow the draft guidance for industry 
Comparative Analyses and Related Comparative Use Human Factors Studies for 
a Drug-Device Combination Product Submitted in an ANDA for the user interface 
of the proposed product.   
b.  If there are design differences identified in the user interface of the proposed 
product as compared to the RLD, identify the proposed formulation and/or data 
you propose to submit (e.g., in vitro data, comparative human factor study). 
c.  Applicants are encouraged to include specific considerations for their proposed 
product as compared to the RLD with regard to the user interface.  
d.  Other noteworthy items for user interface assessment.    
 
10. Chemistry Manufacturing Control (CMC) 
a.  Complex active pharmaceutical ingredient (API) 
i.  No 
ii.  Yes 
b.  Comparative tests for supporting API sameness (if applicable) 
c.  Novel or unique approaches used in development, manufacture, and control 
strategy of the drug product 
d.  Comparative tests for supporting Q1 sameness/similarity of complex functional 
excipients (if applicable) 
e.  Other noteworthy items for CMC (e.g., complex device and related quality 
considerations) 
 
11. Supplemental Materials 
a.  A list of supplemental materials, if any 
 
 
 
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