| Administrative/Procedural |
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products |
Draft |
9/22/2023 |
| Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality |
Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications |
Draft |
9/22/2023 |
| Emergencies |
Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies |
Final |
9/21/2023 |
| Labeling |
Regulatory Considerations for Prescription Drug Use-Related Software |
Draft |
9/19/2023 |
| Clinical - Medical |
Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence |
Draft |
9/19/2023 |
| Biosimilars |
Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1) |
Draft |
9/18/2023 |
| Biosimilars |
Labeling for Biosimilar and Interchangeable Biosimilar Products |
Draft |
9/18/2023 |
| Food & Drug Administration Modernization Act of 1997 |
Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry
|
Final |
9/15/2023 |
| Clinical - Pharmacology |
Clinical Pharmacology Considerations for Peptide Drug Products |
Draft |
9/11/2023 |
| Good Clinical Practice (GCP) |
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products |
Final |
9/11/2023 |
| Clinical - Medical |
Endogenous Cushing’s Syndrome: Developing Drugs for Treatment |
Draft |
9/08/2023 |
| Generics |
Post-Warning Letter Meetings Under GDUFA |
Draft |
9/05/2023 |
| Administrative/Procedural |
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies |
Final |
9/01/2023 |
| Real World Data / Real World Evidence (RWD/RWE), Clinical - Medical |
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products |
Final |
8/30/2023 |
| Administrative/Procedural |
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act |
Final |
8/30/2023 |
| Administrative/Procedural |
Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies |
Final |
8/28/2023 |
| Biosimilars |
Classification Categories for Certain Supplements Under BsUFA III
|
Draft |
8/11/2023 |
| Biosimilars |
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry
|
Draft |
8/11/2023 |
| User Fees |
PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR |
Draft |
8/03/2023 |
| Administrative/Procedural |
Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act |
Final |
8/03/2023 |
| Administrative/Procedural |
Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief |
Draft |
8/02/2023 |
| Drug Competition Action Plan, Administrative/Procedural |
CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality |
Final |
7/26/2023 |
| FDAAA |
Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act |
Draft |
7/14/2023 |
| Clinical - Medical |
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development |
Draft |
7/12/2023 |
| |
Submitting Nonclinical Datasets for Evaluation of Rodent Carcinogenicity Studies of Pharmaceuticals |
Final |
5/01/2021 |
| Clinical - Medical |
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment |
Final |
6/29/2023 |
| Compounding |
Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act |
Draft |
6/27/2023 |
| Advertising |
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements |
Final |
6/27/2023 |
| Clinical - Medical |
Psychedelic Drugs: Considerations for Clinical Investigations |
Draft |
6/23/2023 |
| Administrative/Procedural |
Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act |
Draft |
6/23/2023 |
| Clinical - Medical |
Clinical Drug Interaction Studies with the Combined Oral Contraceptives Guidance for Industry |
Final |
6/8/2023 |
| ICH-Efficacy |
E6(R3) GOOD CLINICAL PRACTICE (GCP) |
Draft |
6/7/2023 |
| Generic Drugs |
Cover Letter Attachments for Controlled Correspondences and ANDA Submissions |
Final |
6/05/2023 |
| Pharmacology/Toxicology |
Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals |
Final |
6/05/2023 |
| Clinical - Medical |
Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment |
Draft |
6/02/2023 |
| Clinical - Medical |
Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry |
Final |
6/02/2023 |
| Clinical - Medical |
Migraine: Developing Drugs for Preventive Treatment |
Draft |
6/01/2023 |
| Clinical - Medical |
Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products |
Draft |
5/26/2023 |
| |
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products |
Final |
5/25/2023 |
| Electronic Submissions |
Study Data Technical Conformance Guide - Technical Specifications Document |
Final |
5/24/2023 |
| Pharmacology/Toxicology |
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers |
Final |
5/25/2023 |
| Pharmacology/Toxicology |
Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information |
Draft |
5/25/2023 |
| Administrative/Procedural |
Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations |
Draft |
5/18/2023 |
| Administrative/Procedural |
Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act |
Draft |
5/18/2023 |
| Compliance |
Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol |
Final |
5/8/2023 |
| User Fees |
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022 |
Final |
5/1/2023 |
| ICH - Quality |
Q9(R1) Quality Risk Management |
Final |
5/3/2023 |
| Clinical - Medical |
Decentralized Clinical Trials for Drugs, Biological Products, and Devices |
Draft |
5/3/2023 |
| ICH-Safety |
S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS |
Final |
5/1/2023 |
| Clinical - Medical |
Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products |
Final |
5/1/2023 |
| Animal Rule |
Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment |
Draft |
4/20/2023 |
| Over the Counter |
Over-the-Counter Monograph Order Requests: Format and Content |
Draft |
4/13/2023 |
| Generics |
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs |
Draft |
4/13/2023 |
| Generics |
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry |
Draft |
4/13/2023 |
| Administrative/Procedural |
A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers |
Final |
4/12/2023 |
| Administrative/Procedural |
Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making |
Draft |
4/5/2023 |
| Administrative/Procedural |
Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act |
Draft |
4/5/2023 |
| Electronic Submissions |
Identification of Medicinal Products — Implementation and Use |
Final |
3/30/2023 |
| Administrative/Procedural |
Pharmacogenomic Data Submissions |
Draft |
3/17/2023 |
| Clinical - Medical |
Development of Local Anesthetic Drug Products With Prolonged Duration of Effect |
Draft |
3/15/2023 |
| Administrative/Procedural |
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers |
Draft |
3/15/2023 |
| ICH - Quality |
Q13 Continuous Manufacturing of Drug Substances and Drug Products |
Final |
3/1/2023 |
| Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) |
Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens |
Draft |
3/1/2023 |
| Clinical - Medical |
Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment |
Draft |
2/24/2023 |
| Generics |
Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA |
Draft |
2/17/2023 |
| ICH - Multidisciplinary |
M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms |
Draft |
1/31/2023 |
| Real World Data/Real World Evidence (RWD/RWE) |
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products |
Draft |
1/31/2023 |
| Clinical - Pharmacology |
Acromegaly: Developing Drugs for Treatment |
Draft |
1/30/2023 |
| Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) |
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry |
Final |
1/23/2023 |
| Clinical - Medical |
Mpox: Development of Drugs and Biological Products |
Draft |
1/19/2023 |
| Labeling |
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format |
Draft |
1/12/2023 |
| Drug Safety |
Format and Content of a REMS Document |
Final |
1/4/2023 |
| ICH - Multidisciplinary |
M11 Template: Clinical Electronic Structured Harmonised Protocol |
Draft |
12/21/2022 |
| ICH - Multidisciplinary |
M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol |
Draft |
12/21/2022 |
| ICH - Multidisciplinary |
M11 Clinical Electronic Structured Harmonised Protocol |
Draft |
12/21/2022 |
| Generic Drugs |
Controlled Correspondence Related to Generic Drug Development |
Draft |
12/21/2022 |
| Labeling |
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims |
Final |
12/15/2022 |
| Clinical-Antimicrobial |
Pulmonary Tuberculosis: Developing Drugs for Treatment |
Draft |
12/14/2022 |
| Generics |
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry |
Final |
12/14/2022 |
| Compliance |
Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry |
Final |
12/7/2022 |
| Clinical - Medical |
Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations |
Draft |
12/6/2022 |
| ICH-Safety |
E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials |
Final |
12/5/2022 |
| Generics |
Statistical Approaches to Establishing Bioequivalence |
Draft |
12/2/2022 |
| Generics |
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions |
Draft |
12/2/2022 |
| Clinical-Antimicrobial |
Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act |
Final |
11/18/2022 |
| ICH-Quality |
Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin |
Draft |
11/10/2022 |
| Generics |
Sameness Evaluations in an ANDA — Active Ingredients |
Draft |
11/8/2022 |
| Clinical - Medical |
M10 Bioanalytical Method Validation and Study Sample Analysis |
Final |
11/4/2022 |
| Clinical - Medical |
Cross Labeling Oncology Drugs in Combination Regimens |
Final |
11/2/2022 |
| ICH-Safety |
S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals |
Final |
11/2/2022 |
| User Fees |
Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program |
Draft |
11/1/2022 |
| Clinical - Medical |
Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials |
Draft |
10/31/2022 |
| Clinical - Antimicrobial |
Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention |
Draft |
10/27/2022 |
| Administrative/Procedural |
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products |
Final |
10/27/2022 |
| Generics |
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence |
Draft |
10/21/2022 |
| Generics |
In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs |
Draft |
10/21/2022 |
| Generics |
In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs |
Draft |
10/21/2022 |
| Generics |
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs |
Draft |
10/21/2022 |
| Biostatistics |
Multiple Endpoints in Clinical Trials |
Final |
10/20/2022 |
| Clinical - Medical |
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA |
Final |
10/13/2022 |
| Generics |
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA |
Final |
10/5/2022 |
| Generics |
Competitive Generic Therapies |
Final |
10/5/2022 |
| Generics |
Facility Readiness: Goal Date Decisions Under GDUFA |
Draft |
10/3/2022 |
| Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) |
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA |
Draft |
10/3/2022 |
| Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) |
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules |
Final |
10/3/2022 |
| Electronic Submissions |
Providing Over-the-Counter Monograph Submissions in Electronic Format |
Draft |
9/27/2022 |
| Administrative/Procedural |
Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry |
Final |
9/22/2022 |
| Administrative/Procedural |
How To Obtain a Covered Product Authorization |
Draft |
9/21/2022 |
| Labeling |
Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products |
Draft |
9/8/2022 |
| Labeling |
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products |
Draft |
9/8/2022 |
Real World Data/Real World Evidence (RWD/RWE)
Administrative/Procedural |
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products |
Final |
9/8/2022 |
| |
E11A Pediatric Extrapolation |
Draft |
8/26/2022 |
| ICH-Multidisciplinary |
M12 Drug Interaction Studies |
Draft |
8/26/2022 |
| ICH-Quality |
Q14 Analytical Procedure Development |
Draft |
8/26/2022 |
| ICH-Quality |
Q2(R2) Validation of Analytical ProceduresQ14 Analytical Procedure Development |
Draft |
8/26/2022 |
| ICH-Efficacy, ICH-Safety |
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers |
Final |
8/26/2022 |
|
|
| Generics |
In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs |
Draft |
10/21/2022 |
| Generics |
In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs |
Draft |
10/21/2022 |
| Generics |
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs |
Draft |
10/21/2022 |
| Biostatistics |
Multiple Endpoints in Clinical Trials |
Final |
10/20/2022 |
| Clinical - Medical |
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA |
Final |
10/13/2022 |
| Generics |
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA |
Final |
10/5/2022 |
| Generics |
Competitive Generic Therapies |
Final |
10/5/2022 |
| Generics |
Facility Readiness: Goal Date Decisions Under GDUFA |
Draft |
10/3/2022 |
| Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) |
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA |
Draft |
10/3/2022 |
| Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) |
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules |
Final |
10/3/2022 |
| Electronic Submissions |
Providing Over-the-Counter Monograph Submissions in Electronic Format |
Draft |
9/27/2022 |
| Administrative/Procedural |
Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry |
Final |
9/22/2022 |
| Administrative/Procedural |
How To Obtain a Covered Product Authorization |
Draft |
9/21/2022 |
| Labeling |
Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products |
Draft |
9/8/2022 |
| Labeling |
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products |
Draft |
9/8/2022 |
Real World Data/Real World Evidence (RWD/RWE)
Administrative/Procedural |
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products |
Final |
9/8/2022 |
| |
E11A Pediatric Extrapolation |
Draft |
8/26/2022 |
| ICH-Multidisciplinary |
M12 Drug Interaction Studies |
Draft |
8/26/2022 |
