1 

CDER Guidance Agenda 

New & Revised Draft Guidance Documents 

Planned for Publication in Calendar Year 20231

(July 2023)

(See the Good Guidance Practices (GGPs) regulation on this Web page or 

21 CFR 10.115 for details about the Guidance Agenda.)

CATEGORY – Administrative/Procedural

• Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements

• Classification Categories for Certain Supplements Under 351(k) of the PHS Act

• Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and 

Answers

• Exclusivity for First Interchangeable Biosimilar Biological Products 

• Fixed Dose Combinations and Single-Entity Versions of Previously Approved 

Antiretrovirals for the Treatment of Human Immunodeficiency Virus-1 Under President’s 

Emergency Plan for AIDS Relief (PEPFAR)

• Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders 

Under Section 505G of the Food, Drug, and Cosmetic Act2

• Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products;

Revised Draft

• Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; 

Revised Draft3

• Institutional Review Board (IRB) Review of Individual Patient Expanded Access 

Requests for Investigational Drugs and Biological Products 

• Key Information and Facilitating Understanding in Informed Consent for FDA-Regulated 

Clinical Investigations

• Master Protocols for Drug Development and Biological Product Development 

• Notification of a Permanent Discontinuance or Interruption in Manufacturing Under 

Section 506C of the FD&C Act2

• Pediatric Drug Development: Regulatory Considerations-Complying with the Pediatric 

Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best 

Pharmaceuticals for Children Act2

• Pediatric Drug Development Under the Pediatric Research Equity Act and the Best 

Pharmaceuticals for Children Act: Scientific Considerations2

• Porcine Derived Thyroglobulin Products 

• Priority Review Voucher Programs

• Responding to CGMP Observations on Form FDA 483 

1 Final guidance documents planned for publication in calendar year 2023 are not included on this list unless 

otherwise noted. CDER is not bound by this list of topics nor required to issue every guidance document on this list. 

We are not precluded from developing guidance documents on topics not on this list.

2 Published since the January 2023 posting

3 Added since the January 2023 posting
2

• Use of Generally Accepted Scientific Knowledge in Applications for Drugs and 

Biological Products: Nonclinical Information4

CATEGORY – Animal Rule

• Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment4

CATEGORY – Biosimilars

• Considerations in Demonstrating Interchangeability with a Reference Product Update5

• Pediatric Study Plans for Biosimilar Products5

• Product Class-Specific Recommendations for Developing Biosimilar and Interchangeable 

Biological Products

 

CATEGORY – Clinical/Antimicrobial

• Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for 

Treatment4

CATEGORY – Clinical/Medical 

• Chronic Pain: Developing Drugs for Treatment

• Decentralized Clinical Trials4

• Demonstrating Substantial Evidence Standard Based on One Adequate and WellControlled Clinical Investigation and Confirmatory Evidence

• Development of 351(a) Biologics License Applications for Thyroid Products

• Development of Local Anesthetic Drug Products with Prolonged Duration of Effect4

• Developing Products for Chronic Weight Management; Revised Draft5

• Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including 

Addressing the Impact of Emergent Variants for Emergency Use Authorization5

• Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic 

Drugs and Biological Products4

• Diabetic Foot Infections: Developing Drugs for Treatment5

• Drugs With Teratogenic Potential-Recommendations for Pregnancy Planning and 

Prevention

• Early Alzheimer’s Disease: Developing Drugs for Treatment; Revised Draft5

• Endogenous Cushing's Syndrome: Developing Drugs for Treatment

• Inborn Errors of Metabolism That Use Dietary Management: Considerations for 

Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development4

• Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs 

for Treatment4

• Migraine: Developing Drugs for Preventive Treatment4

• Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment

• Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment

• Protocol Deviations

4 Published since the January 2023 posting 5 Added since the January 2023 posting
3

• Psychedelic Drugs: Considerations for Scientific Investigations6

• Stimulant Use Disorders: Developing Drugs for Treatment

• Use of Data Monitoring Committees in Controlled Clinical Trials

CATEGORY – Clinical Pharmacology

• Clinical Pharmacology Considerations for Peptides

• Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and 

Recommendations for Labeling

• Pharmacogenomic Data Submission6

CATEGORY – Compounding

• Compounded Drug Products That Are Essentially Copies of a Commercially Available 

Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised 

Draft 

• Compounded Drug Products That Are Essentially Copies of Approved Drug Products 

Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Revised Draft 

• Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the 

Federal Food, Drug and Cosmetic Act7

• Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the 

Federal Food, Drug and Cosmetic Act7

• Nomination of Bulk Drug Substances for Use in Compounding Under Section 503B of 

the Federal Food, Drug, and Cosmetic Act

• Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal 

Food, Drug, and Cosmetic Act; Revised Draft

• Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and 

Cosmetic Act6

• Safety Considerations for Container Labels and Carton Labeling Design to Minimize 

Medication Errors-Guidance for Outsourcing Facilities Under Section 503B of the FD&C 

Act

CATEGORY – Drug Development Tools

• Biomarker Qualification: Evidentiary Framework

CATEGORY – Drug Safety 

• Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance 

with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act6

• Development of a Shared System or Separate Comparable Risk Evaluation and 

Mitigation Strategies; Revised Draft

• Purpose and Content of Use-Related Risk Analyses

6 Published since the January 2023 posting

7 Added since the January 2023 posting
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CATEGORY – Electronic Submissions 

• Identification of Medicinal Products: Implementation and Use

• NDC Assignment of Human Drugs including Biological Products

• Group Purchasing Organization vs. Private Label Distributor

• Repackagers and Relabelers of Human Drugs: Labeling; Registration and Listing, Safety 

Reporting, Supply Chain Security, and Good Manufacturing Practice

CATEGORY – Generics

• 180-Day Exclusivity: Questions and Answers; Revised Draft

• 30-Month Stay of Approval of a 505(b)(2) Application or an ANDA

• ANDA Submissions-Amendments to Abbreviated New Drug Applications Under 

GDUFA; Revised Draft

• ANDA Submissions-Amendments and Requests for Final Approval to Tentatively 

Approved ANDAs

• ANDA Submissions-Refuse-to-Receive for DMF Facilities Deficiencies 

• ANDA Submissions-Refuse-to-Receive Standards: Questions and Answers

• Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for 

ANDAs; Revised Draft8

• Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery 

Systems for Abbreviated New Drug Applications; Revised Draft8

• Comparative Analyses and Related Comparative Use Human Factors Studies for a DrugDevice Combination Product Submitted in an ANDA; Revised Draft 

• Content and Format of Composition Tables in NDAs and ANDAs And Corresponding 

Statement of Ingredients in Labeling

• Data Integrity for Bioavailability and Bioequivalence Studies at Testing Sites9

• Determining Whether to Submit an ANDA or 505(b)(2) Application

• Handling and Retention of BA and BE Testing Samples

• New Clinical Investigation Exclusivity for Drug Products: Questions and Answers10

• “Open for Business” Definition Under 744B of the Federal Food, Drug and Cosmetic Act

• Pediatric Exclusivity General Considerations for ANDAs

• Post Warning Letters Under GDUFA11

• Product Specific Guidance Meetings Between FDA and ANDA Applicants under 

GDUFA8

• Requests for Reconsideration at the Division Level Under GDUFA11

CATEGORY – ICH

• E2D(R1) Post-Approval Safety Data Management: Definitions and Standards for 

Expedited Reporting

• E6(R3) Good Clinical Practice Principles and Annex 1

8 Published since the January 2023 posting

9 Title revised from “ANDA and NDA Submissions: Data Integrity for BA/BE Studies at Testing Sites 10 Title revised from “Three-Year Exclusivity for Drug Products” 11 Added since the January 2023 posting
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• E6(R3) Good Clinical Practice Annex 212

• E20 Adaptive Clinical Trials

• M4Q(R2) Revision of M4Q(R1) CTD on Quality 

• M11 Clinical Electronic Structured Harmonised Protocol12

• M13B Bioquivalence for Additional Solid, Oral Dosage Strengths Including Biowaiver 

Considerations12

• M14 General Principles on Planning and Designing Pharmacoepidemiological Studies 

that Utilize Real-World Data for Safety Assessment 

• Q2(R2)/Q14 Analytical Validation12

• Q3E Impurity: Assessment and Control of Extractables and Leachables for 

Pharmaceuticals and Biologics

• Q5A(R2) Biotechnology Products Derived from Cell Lines of Human or Animal Origin

CATEGORY – Labeling

• Combined Hormonal Contraceptives for Prevention of Pregnancy-Labeling for Health 

Care Providers and Patients

• Draft Interaction Section of Labeling for Human Prescription Drug and Biological 

Products – Content and Format12

• Labeling for Biosimilar and Interchangeable Biosimilar Products

• Pharmacokinetics in Patients with Impaired Hepatic Function – Study Design, Data 

Analysis, and Impact on Dosing and Labeling; Revised Draft12

• Regulatory Considerations for Prescription Drug Use-Related Software 

CATEGORY– Over-the-Counter Drugs

• Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug 

Products

• Formal Dispute Resolution and Consolidated Proceedings: Requestor of OMUFA 

Products Appeals Above the Division Level

• OTC Monographs Order Requests (OMORs)-Format and Content of Data Submissions13

CATEGORY – Pharmaceutical Quality CGMP

• PET Drugs - Current Good Manufacturing Practice (CGMP); Revised Draft

CATEGORY – Pharmaceutical Quality/CMC

• Advanced Manufacturing Technologies Designation Program Designated Technologies 

in Drug and Biological Products

• ANDAs: Stability Testing of Drug Substances and Products Q & A 

• Approaches to Meeting CGMP Requirements for Distributed Manufacturing12

• Container Closure Systems for Drugs, Including Biological Products

• Considerations for Complying with 21 CFR 211.11012

12 Added since the January 2023 posting 13 Published since the January 2023 posting
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• Control of Nitrosamine Impurities in Human Drugs; Immediately in Effect Upon 

Publication (Revision 2)14

• Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic 

Proteins Targeting Viral Pathogens14

• Products With Benzene-Containing Carbomers: Recommendations for Reformulation

• Quality Considerations for Topical Ophthalmic Drug Products

• Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring 

Facilities14

• Stability Considerations for Drug Substances and Drug Products in NDAs, ANDAs, and 

BLAs and Associated Labeling Statements for Drug Products

• Stability Recommendations for Additional Manufacturing Facilities in NDAs, ANDAs 

and BLAs, and Additional Drug Substance Sources in NDAs and ANDAs

• Postapproval Manufacturing Changes to Biosimilars and Interchangeable Biosimilars

Questions and Answers

• Use of Alternative Tools to Assess Manufacturing Facilities Named in Pending 

Applications

CATEGORY – Pharmacology/Toxicology

• Translation of Nonclinical Toxicology Study Reports: Questions and Answers

• Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related 

Impurities (NDSRIs); Immediately in Effect Upon Publication14

CATEGORY – Real-World Data/Real-World Evidence (RWD/RWE)

• Considerations for the Design and Conduct of Externally Controlled Trials for Drug and 

Biological Products15

• Considerations Regarding Non-Interventional Studies for Drug and Biological Products

• Using Clinical Practice Data in Randomized Controlled Trials (RCT) for Regulatory 

Decision-Making for Drug and Biological Products

Note: Agenda items reflect guidances under development as of the date of this posting.

14 Added since the January 2023 posting 15 Published since the January 2023 posting