+Items related to biologics will be added to the top of the list as they are posted on the site.
03/9/2026 March 6, 2026 Approval Letter - Standardized Bermuda Grass (Cynodon dactylon) Grass Pollen 03/09/2026 SOPP 8110: Submission of Regulatory Applications -- Exempt from eCTD Requirements 03/09/2026 Questions and Answers on Biosimilar Development and the BPCI Act; Guidance for Industry 03/06/2026 February 17, 2026 Approval Letter - Elecsys HBsAg II 03/06/2026 Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection; Draft Guidance for Industry 03/04/2026 Advancing Pediatric Cell and Gene Therapy Clinical Trials: Scientific, Ethical, Regulatory, and Practical Considerations 03/03/2026 BK251232- PRF-Matrix System 03/02/2026 February 25, 2026 Approval Letter - PAPZIMEOS 12/27/2025 February 26, 2026 Approval Letter - AUCATZYL 12/27/2025 February 24, 2026 Clinical Memo - AUCATZYL 02/24/2026 BK251292- NexSys PCS® Plasma Collection System with Persona Plus Technology 02/24/2026 February 20, 2026 Approval Letter - Fluzone Southern Hemisphere and Fluzone High-Dose Southern Hemisphere 02/23/2026 February 20, 2026 Approval Letter - BREYANZI 02/23/2026 February 20, 2026 Approval Letter - COMIRNATY 02/23/2026 Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause; Draft Guidance for Industry 02/17/2026 February 13, 2026 Approval Letter - SHINGRIX 02/17/2026 BK251296- PUREGRAFT SYNC Adipose Filtration System 02/12/2026 February 11, 2026 Approval Letter - OMISIRGE 02/12/2026 February 5, 2026 Approval Letter - YESCARTA 02/12/2026 January 27, 2026 Approval Letter - THYMOGLOBULIN 02/12/2026 Vaccines and Related Biological Products Advisory Committee March 12, 2026 Meeting Announcement 02/11/2026 February 10, 2026 Approval Letter - 0.8% RESOLVE Panels, A, B, and C
Content current as of:
03/09/2026
