New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)-2026/3/9

Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk-2026/3/9

Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection-2026/3/6

E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports-2026/3/3

M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines-2026/3/3

New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers-2026/3/3

Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause-2026/2/23

Questions and Answers About Requirements for Additional Traceability Records for Certain Foods-2026/2/19

Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food-Producing Animals-2026/2/12

Certification Process for Designated Medical Gases-2026/2/11