| 04/03/2026 | BK251289- Plasmacell-C Disposable Set |
| 04/02/2026 | April 1, 2026 Approval Letter - TECARTUS |
| 04/02/2026 | SOPP 8404.1: Procedures for Filing an Application When the Applicant Protests a Refusal to File Action (File Over Protest) |
| 04/02/2026 | Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle; Guidance for Industry and Food and Drug Administration Staff |
| 03/30/2026 | March 27, 2026 Approval Letter - PRIORIX |
| 03/27/2026 | BK251300- Procleix Plasmodium Quality Control |
| 03/27/2026 | March 26, 2026 Approval Letter - KRESLADI |
| 03/26/2026 | Advancing Pediatric Cell and Gene Therapy Clinical Trials: Scientific, Ethical, Regulatory, and Practical Considerations
Agenda added |
| 03/25/2026 | March 18, 2026 Approval Letter - CASGEVY |
| 03/25/2026 | March 23, 2026 Approval Letter - AFLURIA |
| 03/24/2026 | March 13, 2026 Summary Basis for Regulatory Action - Procleix Plasmodium Assay |
| 03/24/2026 | March 23, 2026 Approval Letter - Flucelvax and Flucelvax Quadrivalent |
| 03/24/2026 | March 23, 2026 Approval Letter - Fluarix |
| 03/24/2026 | March 23, 2026 Approval Letter - FluLaval |
| 03/24/2026 | March 23, 2026 Approval Letter - Fluzone Southern Hemisphere |
| 03/24/2026 | March 23, 2026 Approval Letter - Fluzone and Fluzone Quadrivalent |
| 03/24/2026 | Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot CL6814 through June 30, 2026
Safety Communication |
| 03/19/2026 | Pyrogen and Endotoxins Testing: Questions and Answers; Guidance for Industry |
| 03/18/2026 | March 12, 2026 Approval Letter - Quadracel |
| 03/18/2026 | March 12, 2026 Approval Letter - Pentacel |
| 03/18/2026 | Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma
Webinar Date: May 12, 2026 |
| 03/17/2026 | March 6, 2026 Approval Letter - Elecsys Anti-HCV II |
| 03/17/2026 | March 16, 2026 Approval Letter - Procleix Plasmodium Assay |
| 03/17/2026 | SOPP 8215: Management of Regenerative Medicine Advanced Therapy Products: Request for Designation, Sponsor Interactions, and Status Assessment |
| 03/16/2025 | March 12, 2026 Approval Letter - VAXELIS |
| 03/16/2026 | SOPP 8412: Review of Product Labeling |
| 03/16/2026 | March 13, 2026 Approval Letter - RotaTeq |
| 03/16/2026 | BK251299- PlateletQuick PRP |
| 03/13/2026 | Influenza Vaccine Composition for the 2026-2027 U.S. Influenza Season |
| 03/13/2026 | March 12, 2026 Approval Letter - AREXVY |
| 03/13/2026 | SOPP 8401.2: Administrative Processing of BLA and NDA Supplements |
| 03/12/2026 | Patient and Consumer Warning about Potential Serious Risks of Harm following Use of Unapproved Products from Human Cells or Tissues
Safety Communication |
| 03/11/2026 | February 20, 2026 Clinical Review Memo - BREYANZI |
| 03/11/2026 | BK251294- Hemanext ONE |
| 03/10/2026 | October 8, 2024 Approval Letter - PROCLEIX WNV ASSAY |
| 03/10/2026 | March 4, 2025 Approval Letter - Alinity s HTLV I/II |
| 03/10/2026 | June 7, 2024 Approval Letter - Alinity s HBsAg and Alinity s HBsAg Confirmatory |
| 03/10/2026 | March 28, 2024 Approval Letter - cobas® TaqScreen WNV Test |
| 03/10/2026 | January 8, 2025 - Approval Letter Alinity s Anti-HBc assay |
| 03/09/2026 | 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
Workshop Date: April 9, 2026 |
| 03/03/2026 | BK251232- PRF-Matrix System |
