CDERs Program for the 
Recognition of Voluntary 
Consensus Standards Related 
to Pharmaceutical Quality 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
July 2023 
Administrative/Procedural 
 
   
CDERs Program for the 
Recognition of Voluntary 
Consensus Standards Related 
to Pharmaceutical Quality  
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) 
 
July 2023 
Administrative/Procedural 
 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  SCOPE OF THE PROGRAM ......................................................................................... 3 
IV.  PURPOSE OF THE PROGRAM .................................................................................... 3 
V.  THE RECOGNITION PROGRAM FOR VOLUNTARY CONSENSUS 
STANDARDS RELATED TO PHARMACEUTICAL QUALITY ............................. 4 
A.  Elements of the Standards Development Process ....................................................................... 4 
1. Openness .......................................................................................................................................... 4 
2. Balance ............................................................................................................................................ 4 
3. Due Process ..................................................................................................................................... 4 
4. Appeals Process ............................................................................................................................... 5 
5. Consensus ........................................................................................................................................ 5 
B.  CDERs Policies and Procedures for Evaluating Voluntary Consensus Standards Related  
to Pharmaceutical Quality ............................................................................................................ 5 
1. Recognition Request Submission and Communication With Requestors ......................................... 5 
2. Recognition Request Evaluation ...................................................................................................... 6 
3. Updating the CDER Programs Recognized Standards Database .................................................. 7 
VI.  QUESTIONS AND ANSWERS ABOUT THE PROGRAM ........................................ 7 
A.  What Does It Mean if CDER Recognizes a Voluntary Consensus Standard? ......................... 7 
B.  How Would the Use of Recognized Standards Benefit the Pharmaceutical Industry? ........... 8 
C.  Does the CDER Standards Recognition Program Include FDA Participation in Standards 
Development Activities? ................................................................................................................ 8 
D.  Will the CDER Program Communicate With SDOs Regarding Recognition Requests? ....... 8 
E.  Where Are the Recognized Standards Posted? ........................................................................... 9 
F.  What Information Accompanies a Recognized Standard? ........................................................ 9 
G.  Can Multiple Standards Be Recognized for the Same Intended Purpose? .............................. 9 
H.  If There Is an Enforceable Compendial Standard From the USP and CDER Has 
Recognized Another Standard for the Same Purpose, What Is the Effect of CDERs 
Recognition? ................................................................................................................................... 9 
I.  What Are CDERs Expectations When a Recognized Standard Is Referenced in a 
Marketing Application? .............................................................................................................. 10 
J.  What Are CDERs Expectations When a Recognized Standard Is Referenced for Drug 
Products That Are Legally Marketed Without an Approved Application? ........................... 10 
K.  How Will the CDER Program Affect Other FDA Centers? .................................................... 10 
  Contains Nonbinding Recommendations 
CDERs Program for the Recognition of Voluntary Consensus 
Standards Related to Pharmaceutical Quality 
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 a program at FDAs Center for Drug Evaluation and Research (CDER) 
to make public a comprehensive listing of recognized voluntary consensus standards2 related to 
pharmaceutical quality.  FDAs participation in the development and use of technical voluntary 
consensus standards has been integral to the execution of FDAs mission.  For example, FDA 
has used such standards to develop and/or evaluate performance characteristics of dosage forms, 
testing methodologies, manufacturing practices, product standards, scientific protocols, 
ingredient specifications, labeling of drug products, and other technical or policy criteria.   
 
 
1 This guidance has been prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation and 
Research at the Food and Drug Administration. 
 
2 In this guidance, the phrase voluntary consensus standard refers to 
 
a standard that is developed or adopted by domestic and international voluntary consensus 
standards bodies . . . .  These bodies often have . . . policies that include provisions requiring that 
owners of relevant patented technology incorporated into a standard make that intellectual 
property available to implementers of the standard on non-discriminatory and royalty-free or 
reasonable royalty terms. 
 
Office of Management and Budget Circular A-119 Revised, Federal Participation in the Development and Use of 
Voluntary Consensus Standards and in Conformity Assessment Activities (revised on January 27, 2016), available at 
https://www.nist.gov/system/files/revised_circular_a-119_as_of_01-22-2016.pdf.  Voluntary consensus standards 
bodies refer to any association, organization, or technical society that plans, develops, establishes, or coordinates 
voluntary consensus standards using a voluntary consensus standards development process that includes [specific] 
attributes or elements.  Ibid.  
 
Section V.A. of this guidance describes these attributes or elements. 
  1  Contains Nonbinding Recommendations 
This program facilitates submissions by external stakeholders3 and FDA staff proposing 
voluntary consensus standards related to pharmaceutical quality for recognition.  CDER believes 
that this program will help promote beneficial innovation in pharmaceutical development and 
manufacturing and streamline the preparation and assessment of marketing applications for 
products regulated by CDER.4   
 
Even if an industry stakeholder references one of CDERs recognized voluntary consensus 
standards to support a product regulated by CDER (e.g., in an application or during an 
inspection), FDA may request additional information that demonstrates that the standard was 
followed and is fit for the intended purpose.  In addition, the stakeholders use of a recognized 
standard is strictly voluntary.   
 
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. 
 
 
II.  BACKGROUND 
 
The National Technology Transfer and Advancement Act (NTTAA) and Office of Management 
and Budget (OMB) Circular A-119 direct Federal Government agencies to use voluntary 
consensus standards developed or adopted by a standards-developing organization (SDO)  
rather than Government-unique standards  except where these standards are inconsistent with 
applicable law or otherwise incompatible with FDAs missions, authorities, priorities, and 
budgetary resources.5 
 
The policies of OMB Circular A-119 are intended to:  (1) encourage Federal agencies to benefit 
from the expertise of the private sector; (2) promote Federal agency participation in voluntary 
consensus standards bodies to ensure the creation of standards that are usable by Federal 
agencies; and (3) reduce reliance on Government-unique standards when an existing voluntary 
standard would suffice.  CDERs program for recognition of voluntary consensus standards is 
consistent with the policies of OMB Circular A-119. 
 
 
 
3 Although regulated industry would be the primary user of standards that are within the scope of this program, any 
interested party may request recognition of a standard.  
 
4 CDERs program is different than the standards recognition program in the Center for Devices and Radiological 
Health.  The Center for Devices and Radiological Health operates a standards recognition program under the Food 
and Drug Administration Modernization Act of 1997 (Public Law 105-115). 
 
5 See section 12(d)(2) of the NTTAA.  
  2  Contains Nonbinding Recommendations 
III.  SCOPE OF THE PROGRAM 
 
This program recognizes voluntary consensus standards related to pharmaceutical quality for 
products under CDERs jurisdiction.  This program considers for recognition both targeted 
standards (e.g., a test method for a specific product type) and standards applicable to a broad 
range of products and processes.6  This program does not apply to statutory and regulatory 
standards that are legally binding, such as certain provisions of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301-399h) relating to the United States Pharmacopeia (USP).7  The 
standards recognized in this program do not include and are different from electronic data 
exchange standards.8     
 
 
IV.  PURPOSE OF THE PROGRAM 
 
CDER established this program to: 
 
  Use FDA expertise to evaluate and, where appropriate, recognize voluntary consensus 
standards related to pharmaceutical quality that are potentially useful to industry and 
FDA staff.  Specifically, this process allows CDER to: 
 
  Receive a candidate consensus standard, with relevant information (e.g., the scope of 
the standard and the purpose), from internal or external parties for recognition  
 
  Determine whether to recognize a standard in whole or in part following an internal 
scientific and policy evaluation 
 
  Prepare an information sheet for each recognized standard describing the scope and 
the extent of CDERs recognition of that standard and any other relevant information 
 
  List the recognized standards and post the information sheets in a publicly searchable 
database on the CDER programs web page9  
 
 
6 Standards applicable to drug-device combination products under CDER jurisdiction and to the drug constituent 
part of such combination products are within the scope of this program.  In certain circumstances, a standard 
applicable to a device constituent part of such combination products under CDER jurisdiction may be considered for 
recognition.  Areas not covered by this program include, for example, standards related to drug product distribution, 
supply chain security, and bioresearch monitoring.  
  
7 Although much of the USP and National Formulary is legally enforceable, the USP general chapters numbered 
<1000> to <1999> (general information chapters) are informational and generally do not contain any mandatory 
requirements (see USP General Notices 3.10, Applicability of Standards). 
 
8 Electronic data exchange standards for submissions to CDER can be found in the FDA Data Standards Catalog, 
which lists the data standards and terminologies that FDA supports for use in regulatory submissions to better enable 
the evaluation of safety, effectiveness, and quality of FDA-regulated products. 
 
9 See https://www.fda.gov/drugs/cder-program-recognition-voluntary-consensus-standards-related-pharmaceutical-
quality-cder-quality. 
  3  Contains Nonbinding Recommendations 
  Provide transparency to external stakeholders regarding CDERs thinking about a 
particular method or approach. 
 
  Promote the visibility and use of standards applicable to its public health mission.  
 
 
V.  THE RECOGNITION PROGRAM FOR VOLUNTARY CONSENSUS 
STANDARDS RELATED TO PHARMACEUTICAL QUALITY 
 
A.  Elements of the Standards Development Process 
 
For purposes of this program, CDER intends to consider for recognition standards developed by 
voluntary consensus standards bodies that adhered to the elements of openness, balance, due 
process, appeals process, and consensus (mentioned in the revised OMB Circular A-11910).  For 
example, standards developed by the International Organization for Standardization and ASTM 
International usually meet these criteria, as do standards developed in adherence with the 
American National Standards Institute Essential Requirements.11  The CDER program may also 
recognize standards developed by professional societies, industry associations, and other 
organizations that adhere to these elements. 
 
1.  Openness 
 
The procedures or processes for participating in standards development are transparent and open 
to interested parties.  Such parties are provided meaningful opportunities to participate in 
standards development on a non-discriminatory basis.12   
  
2.  Balance 
 
A broad range of stakeholders are provided meaningful involvement in the standards 
development process of the voluntary consensus standards body, with no single interest 
dominating the decision-making. 
 
3.  Due Process 
 
The standards development process of the voluntary consensus standards body contains a due 
process provision where (1) that bodys standards development policies and procedures were 
documented and publicly available, and (2) all stakeholders were provided adequate notice of 
that bodys meetings and standards development activities, and given sufficient time to review 
 
10 See footnote 2. 
 
11 See https://www.ansi.org/. 
 
12 See footnote 2. 
 
  4  Contains Nonbinding Recommendations 
drafts and prepare views and objections, access to views and objections of other participants, and 
a fair and impartial process for resolving conflicting views.13   
 
4.  Appeals Process 
 
The standards development process of the voluntary consensus standards body contains an 
appeals provision, which allows that body to impartially handle any procedural appeals. 
 
5.  Consensus 
 
During the development of consensus14 on standards, comments and objections are considered 
using fair, impartial, open, and transparent processes. 
 
B.  CDERs Policies and Procedures for Evaluating Voluntary Consensus 
Standards Related to Pharmaceutical Quality 
 
1.  Recognition Request Submission and Communication With Requestors 
 
FDA staff and external stakeholders can submit a recognition request electronically through the 
CDER Direct NextGen Collaboration Portal (the portal).15  The portal contains the recognition 
request form and step-by-step instructions for recognition request submission.  The standard that 
is the subject of the request could be either a standard that would be a new recognition for the 
CDER program or a new version of a standard that the CDER program has already recognized.  
Requestors will need the following information to prepare a recognition request:   
 
  Name and contact information of the requestor 
 
  Full title of the published standard, including the name of the SDO and any reference 
number and date  
 
  Brief identification of the testing or performance or other characteristics of the drug(s) or 
manufacturing process(es) that would be addressed by the recognition of the standard, 
and the applicability of the standard to pharmaceutical development, establishing quality 
criteria, and/or regulatory assessment 
 
The program will send the following information to the requestor through the portal:  
acknowledgement of request, notification of whether the program will proceed with evaluation 
of the standard, requests for additional information, and the recognition decision.  
 
 
13 Ibid. 
 
14 The revised OMB Circular A-119 defines consensus as a general agreement, but not necessarily unanimity.  
(OMB Circular A-119 Revised; see footnote 2.) 
 
15 The portal can be accessed at https://edm.fda.gov. 
  5  Contains Nonbinding Recommendations 
When the program does not proceed with evaluation of a standard or does not recognize the 
complete standard, the program will communicate the reason(s) for the decision.  For example, 
the program would not proceed with evaluation when the standard is outside of the programs 
scope, when it is unclear whether the standards development process adhered to all the elements 
that are listed in the programs guidance, or when recognition of the standard would not provide 
enough benefit to justify allocation of resources for evaluation of the standard.  The program 
would not recognize the complete standard when the standard conflicts with an existing 
regulation or published guidance.  Other reasons for not proceeding with evaluation or for not 
recognizing the complete standard could apply and would be listed in communication from the 
program. 
 
2.  Recognition Request Evaluation 
 
CDERs Pharmaceutical Quality Standards Working Group (PQSWG) serves as a coordination 
and advisory group for FDAs participation in standards activities associated with 
pharmaceutical quality.  The PQSWG is composed of CDER experts who conduct application 
assessment, compliance, inspection, surveillance, policy, and research activities related to 
pharmaceutical quality.  The PQSWG has developed and documented an internal process for 
evaluating recognition requests.  The process timelines are flexible and depend on the 
complexity of the assignment and the availability of FDA staff with expertise relevant to the 
standard.  
 
The following general policies and procedures apply to the PQSWGs evaluation of each 
recognition request submitted by an internal or external party: 
 
  When the program receives a recognition request, the PQSWG: 
 
  Determines whether each voluntary consensus standard proposed for recognition is in 
conflict with any statute or regulation under which FDA operates and aligns with 
FDAs current thinking on the topic.  
 
  Determines whether each voluntary consensus standard proposed for recognition is 
within the programs scope and adheres to the five elements of standards 
development listed in section V.A. 
 
  Determines whether recognition would provide enough benefit to justify allocation of 
FDA resources for review of the standard for possible recognition. 
 
  If the voluntary consensus standard proposed for recognition meets the PQSWGs 
qualifying criteria: 
 
  The PQSWG recommends the formation of a subgroup of FDA subject matter experts 
(i.e., individuals with the necessary knowledge, experience, training, and skills related 
to the scope of that standard) to review the standard.  When necessary, the PQSWG 
works with relevant experts within FDA organizational units affected by the technical 
content of the standard. 
  6  Contains Nonbinding Recommendations 
 
  The PQSWG may also recommend that an FDA laboratory evaluate the proposed 
standard. 
 
  If the standard will be recognized in whole or in part, the FDA subject matter experts, 
in collaboration with the PQSWG, prepare the information sheet describing the scope 
and the extent of CDERs recognition of that standard and any other relevant 
information about that standard (see section VI.F.).  The PQSWG reviews and 
approves the information sheet before publication on the CDER programs public 
web page. 
 
3.  Updating the CDER Programs Recognized Standards Database 
 
The PQSWG adheres to the following general policies and procedures for updating the CDER 
programs searchable database of recognized standards: 
 
  When a standard is recognized in whole or in part, the PQSWG lists the standard and 
publishes the accompanying information sheet in a searchable database on CDERs 
public web page as soon as practicable and within 6 months of completion of the 
evaluation process.   
 
  The PQSWG periodically reviews the recognized standards database to identify the 
following: 
 
  Standards that have been withdrawn by the SDO or replaced by a new version 
 
  Standards that are no longer in alignment with current pharmaceutical quality-related 
statutes, regulations, or policies under which FDA operates 
 
  Standards that are no longer appropriate for meeting regulatory expectations 
 
  The PQSWG initiates withdrawal of recognition status and evaluation of new versions of 
standards, as appropriate.  The PQSWG may also initiate evaluation of new versions of 
standards in response to a recognition request submission.  
 
  When a new version of a standard is recognized, the PQSWG replaces the previous 
version with the new version in CDERs recognized standards database as soon as 
practicable.  
 
 
VI.  QUESTIONS AND ANSWERS ABOUT THE PROGRAM 
 
A.  What Does It Mean if CDER Recognizes a Voluntary Consensus Standard? 
 
CDERs recognition of a voluntary consensus standard communicates to FDA staff and external 
stakeholders that the standard has been evaluated by the process described in section V.B.2. and 
  7  Contains Nonbinding Recommendations 
has been found to be potentially helpful in satisfying a regulatory requirement.  As stated earlier, 
even when a stakeholder references one of CDERs recognized standards to support a product 
regulated by CDER (e.g., in an application or during an inspection), FDA may request additional 
information that demonstrates that the standard was followed and is fit for the intended purpose. 
FDA may determine that a standard is used in a way that is not applicable to, or appropriate for, 
the specific product or set of circumstances.  Ultimately, FDAs assessment of appropriate use of 
recognized standards is data-driven, risk-based, and patient-centered.  A stakeholders use of any 
such recognized standard is voluntary.  Additionally, the program does not prevent stakeholders 
from using standards that are not listed in the CDER programs database of recognized 
standards.    
 
B.  How Would the Use of Recognized Standards Benefit the Pharmaceutical 
Industry? 
 
The CDER program is intended to promote innovation in pharmaceutical development and 
manufacturing by leveraging the expertise of the pharmaceutical sector and facilitating the 
establishment of shared expectations among industry stakeholders.  Standards recognition by 
CDER complements FDA guidances by providing transparency to industry on CDERs thinking 
on a particular standard, which could help stakeholders more predictably meet regulatory 
expectations for products under CDERs jurisdiction.  For example, use of a recognized standard 
has the potential to streamline an applicants preparation and FDAs assessment of marketing 
applications.  Because CDER, through the PQSWG recognition process described in section 
V.B., would have already evaluated the validity of a particular standard, FDA would be able to 
focus on the output of that standard (e.g., the attribute evaluated by the standard test method).  
The principles of standards development described in section V.A. ensure that these benefits are 
available to all stakeholders. 
 
C.  Does the CDER Standards Recognition Program Include FDA Participation 
in Standards Development Activities? 
 
Participation in standards development activities is outside the scope of the CDER standards 
recognition program, and the program is not intended to replace such activities.  FDA 
participation in development of a standard is not a prerequisite for recognition of that standard, 
nor does FDA participation imply that the standard would be recognized by CDER through the 
program.  The program considers only published standards.  
 
D.  Will the CDER Program Communicate With SDOs Regarding Recognition 
Requests? 
 
If an SDO submits a recognition request, the program will send information regarding the 
request as described in section V.B.  Regardless of the origin of a recognition request, CDER 
may contact the SDO during the evaluation process to determine whether the standard is within 
the programs scope and whether the standard was developed in accordance with the principles 
listed in section V.A.  Otherwise, CDER does not intend to communicate with SDOs regarding a 
request to recognize one or more of its standards.  SDOs that own a standard previously 
  8  Contains Nonbinding Recommendations 
recognized by the program are encouraged to use the programs mailbox16 to communicate any 
plans to revise the standard.  
 
E.  Where Are the Recognized Standards Posted? 
 
CDER maintains a listing of recognized voluntary consensus standards related to pharmaceutical 
quality in a searchable database that may be accessed via CDERs public web page.17  On that 
web page, an information sheet accompanies every recognized standard.  
 
F.  What Information Accompanies a Recognized Standard? 
 
Every consensus standard listed in CDERs searchable database is accompanied by an 
information sheet that specifies the following: 
 
  The organization that developed the standard 
  The full title, version, and date of the standard that is recognized 
  The scope and extent of CDERs recognition of that standard (in whole or in part) 
  Relevant regulations, guidance, and/or supporting publications 
  Any other information pertinent to the use of the standard, as determined by the PQSWG 
 
G.  Can Multiple Standards Be Recognized for the Same Intended Purpose? 
 
Yes.  CDER can recognize multiple standards that meet its criteria for standards development 
and are determined to be useful for stakeholders and CDER staff.   
 
H.  If There Is an Enforceable Compendial Standard From the USP and CDER 
Has Recognized Another Standard for the Same Purpose, What Is the Effect 
of CDERs Recognition? 
 
CDERs recognition of a voluntary consensus standard does not affect the regulatory status of 
the USP standard; however, in this program, CDER may recognize alternate standards that are 
comparable to the USP standard or that provide advantages over the USP standard.18  An 
alternative method or procedure is defined as any method or procedure other than the compendial 
method or procedure for the article in question.  The alternative method or procedure should be 
fully validated and should produce equivalent or better results compared to the compendial 
method or procedure.  This determination would be made by regulators (e.g., during assessment 
of an application or during an inspection).  Although the use of a noncompendial procedure may 
be adequate for release and stability testing, the article that is the subject of a USP monograph 
 
16 CDERStandardsCoordinationRequest@fda.hhs.gov  
 
17 See https://www.fda.gov/drugs/cder-program-recognition-voluntary-consensus-standards-related-pharmaceutical-
quality-cder-quality. 
 
18 The suitability of any analytical procedure used must be verified under actual conditions of use.  See 21 CFR 
211.194(a)(2). 
  9  Contains Nonbinding Recommendations 
must nevertheless comply with compendial standards when tested as directed in the relevant 
monograph.19 
 
I.  What Are CDERs Expectations When a Recognized Standard Is Referenced 
in a Marketing Application? 
 
Applicants should clearly identify the standard (including the version) and demonstrate that the 
standard is fit for the intended purpose.  Any modifications of the standard or use beyond the 
intended scope should be described and would be evaluated by the appropriate CDER 
organizational unit.  If a new version of the standard becomes available while the application is 
being assessed, CDER would determine whether the applicant should reference the new version 
in the application.  Applicants must follow applicable reporting requirements for changes to use 
of a recognized standard after a marketing application has been approved.20  For example, an 
applicant would be required to report postapproval changes to use of a recognized standard that 
assesses the identity, strength, quality, purity, or potency of a drug product as these factors may 
relate to the safety or effectiveness of the drug product.21  Stakeholders could also use 
recognized standards to support premarketing activities (e.g., an investigational new drug 
application).  
 
J.  What Are CDERs Expectations When a Recognized Standard Is Referenced 
for Drug Products That Are Legally Marketed Without an Approved 
Application?  
 
Drug products that are legally marketed without an approved application should clearly identify 
the standard (including the version) and maintain appropriate documentation demonstrating that 
the standard is fit for the intended purpose.  Such information must be readily available for FDA 
review during an inspection.22  
 
K.  How Will the CDER Program Affect Other FDA Centers? 
 
Product quality aspects assessed by FDA centers other than CDER are outside the scope of the 
CDER program.  The CDER program is not intended to establish policies for other FDA centers 
or to affect assessment practices of other FDA centers, including during cross-center actions.  In 
addition, the CDER program is not intended to affect application of the standards recognition 
program in the Center for Devices and Radiological Health.  However, the CDER program 
allows for consultation of FDA staff outside of CDER during evaluation of a standard for 
possible recognition, when appropriate.  
 
 
19 See USP General Notices 3.10, Applicability of Standards. 
 
20 See 21 CFR 314.70, 21 CFR 314.97, or 21 CFR 601.12 regarding changes to an approved new drug application, 
abbreviated new drug application, or biologics license application, respectively. 
 
21 Ibid. 
 
22 See 21 CFR 211.180(c). 
  10