| Generic Drugs, Drug Competition Action Plan, Electronic Submissions | New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers | Draft | 3/3/2026 |
| ICH-Efficacy | E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports | Final | 3/3/2026 |
| ICH-Multidisciplinary | M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines | Final | 3/3/2026 |
| Administrative/Procedural | Certification Process for Designated Medical Gases | Draft | 2/11/2026 |
| ICH-Efficacy | E22 General Considerations for Patient Preference Studies | Draft | 2/6/2026 |
| ICH-Multidisciplinary | M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality | Draft | 1/21/2026 |
| Biostatistics | Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products | Draft | 1/12/2026 |
| Administrative/Procedural | Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act | Final | 12/22/2025 |
| Advertising | Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers | Final | 12/9/2025 |
| Pharmacology/Toxicology | Monoclonal Antibodies: Streamlined Nonclinical Safety Studies | Draft | 12/2/2025 |
| ICH-Quality | Q3E Guideline for Extractables and Leachables | Draft | 12/1/2025 |
| ICH-Quality | Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs | Draft | 12/1/2025 |
| Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality | Current Good Manufacturing Practice for Medical Gases | Draft | 12/1/2025 |
| Generic Drugs | Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use | Final | 11/17/2025 |
| Biosimilars | Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies | Draft | 10/29/2025 |
| Administrative/Procedural | Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers | Final | 10/22/2025 |
| Administrative/Procedural | Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments | Final | 10/22/2025 |
| ICH-Efficacy | E20 Adaptive Designs for Clinical Trials | Draft | 9/30/2025 |
| Clinical - Antimicrobial | Malaria: Developing Drugs for Treatment | Draft | 9/23/2025 |
| Labeling | Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act | Draft | 9/18/2025 |
| Clinical - Antimicrobial | Disseminated Coccidioidomycosis: Developing Drugs for Treatment | Draft | 9/17/2025 |
| Clinical - Medical | Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment | Draft | 9/17/2025 |
| Clinical - Medical | Erosive Esophagitis: Developing Drugs for Treatment | Draft | 9/17/2025 |
| Pharmaceutical Quality, Current Good Manufacturing Practice (CGMP) | Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications | Final | 9/12/2025 |
| Clinical - Medical | Development of Non-Opioid Analgesics for Chronic Pain | Draft | 9/11/2025 |
| ICH-Efficacy | E6(R3) Good Clinical Practice (GCP) | Final | 9/9/2025 |
| Biosimilars | Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations | Final | 9/9/2025 |
| Biosimilars | Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry | Final | 7/18/2025 |
| ICH-Quality | E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials | Draft | 7/18/2025 |
| Clinical - Medical | Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations | Draft | 7/3/2025 |
| Clinical - Antimicrobial | Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers | Final | 6/26/2025 |
| Clinical - Antimicrobial | Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment | Final | 6/26/2025 |
| ICH-Quality | Q1 Stability Testing of Drug Substances and Drug Products | Draft | 6/23/2025 |
| Generic Drugs | Post-Warning Letter Meetings Under GDUFA | Final | 6/20/2025 |
| Pharmaceutical Quality; Chemistry, Manufacturing, and Controls (CMC) | ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions | Final | 6/13/2025 |
| ICH-Multidisciplinary | M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol | Draft | 6/5/2025 |
| ICH-Multidisciplinary | M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP) | Draft | 6/5/2025 |
| Over-the-Counter Drugs | Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs | Draft | 6/4/2025 |
| ICH-Multidisciplinary | M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver | Draft | 6/2/2025 |
| Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC) | Replacing Color Additives in Approved or Marketed Drug Products | Draft | 5/29/2025 |
| Clinical - Medical | Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction | Draft | 1/7/2025 |
| Clinical - Medical | Developing Drugs for Optical Imaging | Draft | 1/7/2025 |
| Clinical - Medical | Study of Sex Differences in the Clinical Evaluation of Medical Products | Draft | 1/6/2025 |
| Compounding and Related Documents | Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Final | 1/6/2025 |
| Compounding and Related Documents | Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act | Final | 1/6/2025 |
| Artificial Intelligence | Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products | Draft | 1/7/2025 |
| Administrative/Procedural | Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers | Draft | 1/6/2025 |
| Pharmaceutical Quality, Current Good Manufacturing Practice (CGMP) | Considerations for Complying with 21 CFR 211.110 | Draft | 1/6/2025 |
| Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC) | Advanced Manufacturing Technologies Designation Program | Final | 12/31/2024 |
| ICH - Multidisciplinary | M15 General Principles for Model-Informed Drug Development | Draft | 12/30/2024 |
| ICH - Efficacy | E11A Pediatric Extrapolation | Final | 12/30/2024 |
| ICH - Efficacy | E6(R3) Good Clinical Practice: Annex 2 | Draft | 12/30/2024 |
| Clinical - Medical | Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices | Draft | 12/30/2024 |
| Technical Specifications Document | Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)\ | Final | 12/13/2024 |
| Procedural | Accelerated Approval – Expedited Program for Serious Conditions | Draft | 12/5/2024 |
| ICH - Multidisciplinary | M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms | Final | 10/30/2024 |
| Labeling / Clinical Pharmacology | Drug Interaction Information in Human Prescription Drug and Biological Product Labeling | Draft | 10/21/2024 |
| Clinical - Medical | Postoperative Nausea and Vomiting: Developing Drugs for Prevention | Draft | 10/17/2024 |
| User Fees | Requests for Reconsideration at the Division Level Under GDUFA | Final | 10/16/2024 |
| Compounding | Temporary Policies for Compounding Certain Parenteral Drug Products | Final | 10/11/2024 |
| Administrative / Procedural | Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers | Final | 10/1/2024 |
| Clinical - Medical | Conducting Clinical Trials With Decentralized Elements | Final | 9/17/2024 |
| Real World Data / Real World Evidence (RWD/RWE) | Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice | Draft | 9/17/2024 |
| Electronic Submissions | Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry | Final | 9/11/2024 |
| Generic Drugs | ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA | Final | 9/11/2024 |
| Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality | Control of Nitrosamine Impurities in Human Drugs | Final | 9/5/2024 |
| ICH - Multidisciplinary | M12 Drug Interaction Studies: Questions and Answers | Final | 8/2/2024 |
| Electronic Submissions | Providing Over-the-Counter Monograph Submissions in Electronic Format | Final | 7/25/2024 |
| Real World Data / Real World Evidence (RWD/RWE) | Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products | Final | 7/25/2024 |
| Biologics | Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers | Draft | 7/23/2024 |
| Clinical - Medical | Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment | Draft | 7/19/2024 |
| Clinical - Pharmacology | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies | Final | 7/18/2024 |
| Clinical - Pharmacology | Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older Guidance for Industry | Final | 7/15/2024 |
| Combination Products | Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products | Draft | 7/08/2024 |
