| Clinical - Medical | Master Protocols for Drug and Biological Product Development | Draft | 6/24/2026 |
| Clinical - Medical | Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products | Draft | 6/24/2026 |
| Clinical Pharmacology | Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials | Draft | 6/24/2026 |
| Clinical Pharmacology | Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug | Final | 6/18/2026 |
| Generic Drugs, Drug Competition Action Plan | Forms FDA 3542a and FDA 3542: Questions and Answers | Draft | 6/15/2026 |
| Generic Drugs | Certain Postapproval Requirements and Resources for ANDAs | Final | 6/4/2026 |
| Administrative/Procedural | Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers | Draft | 6/3/2026 |
| ICH-Multidisciplinary | M15 General Principles for Model-Informed Drug Development | Final | 6/3/2026 |
| ICH-Quality | Q8, Q9, and Q10 Questions and Answers (R5) | Final | 5/29/2026 |
| Biopharmaceutics | Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application | Final | 5/29/2026 |
| Biopharmaceutics | Statistical Approaches to Establishing Bioequivalence | Final | 5/29/2026 |
| ICH-Multidisciplinary | M11 Clinical Electronic Structured Harmonised Protocol | Final | 5/21/2026 |
| Clinical - Medical | Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework | Draft | 5/13/2026 |
| Clinical - Medical | Development of Local Anesthetic Drug Products With Prolonged Duration of Effect | Draft | 5/13/2026 |
| Clinical - Medical | Stimulant Use Disorders: Developing Drugs for Treatment | Draft | 5/13/2026 |
| Clinical - Medical | Development of Non-Opioid Analgesics for Chronic Pain | Draft | 5/13/2026 |
| Clinical - Medical | Development of Non-Opioid Analgesics for Acute Pain | Draft | 5/13/2026 |
| Clinical - Antimicrobial | Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention | Final | 5/8/2026 |
| Clinical - Antimicrobial | Pulmonary Tuberculosis: Developing Drugs for Treatment | Final | 5/8/2026 |
| Clinical - Medical | Postapproval Pregnancy Safety Studies | Final | 5/8/2026 |
| Technical Specifications Document | Submitting Continuous Glucose Monitoring Data in Clinical Trials | Final | 5/7/2026 |
| Pharmaceutical Quality; Chemistry, Manufacturing, and Controls (CMC) | Establishing Impurity Specifications for Antibiotics | Draft | 4/20/2026 |
| Clinical Pharmacology | Bioanalytical Method Validation for Biomarkers | Final | 4/10/2026 |
| Pharmacology/Toxicology | General Considerations for the Use of New Approach Methodologies in Drug Development | Draft | 3/18/2026 |
| Generic Drugs, Drug Competition Action Plan, User Fees, Electronic Submissions | Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs | Final | 3/18/2026 |
| Biosimilars | Questions and Answers on Biosimilar Development and the BPCI Act | Final | 3/10/2026 |
| Biosimilars | New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4) | Draft | 3/10/2026 |
| Current Good Manufacturing Practice (CGMP) | Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection | Draft | 3/9/2026 |
| 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 |
