| 09/23/2026 | September 23, 2026 Approval Letter - ADZYNMA |
| 09/21/2026 | SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products |
| 09/17/2026 | September 17, 2026 Approval Letter - FAYUVI |
| 09/17/2026 | BK261388- INSTI® HIV-1/HIV-2 Antibody Test |
| 09/17/2026 | Electronic Submission Template for Premarket Approval Applications (PMA); Draft Guidance for Industry and Food and Drug Administration Staff |
| 09/17/2026 | September 15, 2026 Approval Letter - CPD, ADSOL Red Preservation Solution, (PL 146) and/or SEPACELL Filter |
| 09/17/2026 | September 15, 2026 Approval Letter - ADSOL Red Cell Preservation Solution (PL 2209) CPD and ADSOL and/or SEPACELL in PL 2209 |
| 09/16/2026 | September 15, 2026 Approval Letter - THROMBIN-JMI LIQUID |
| 09/16/2026 | September 15, 2026 Approval Order - OraQuick HIV Self-Test |
| 09/16/2026 | Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Guidance for Industry |
| 09/14/2026 | Vaccines and Related Biological Products Advisory Committee Meeting Announcement
Date: October 1, 2026 |
| 09/09/2026 | September 8, 2026 Approval Letter - THROMBIN-JMI |
| 09/02/2026 | SOPP 8203: Administrative Processing and Review Management of Charging Requests (Cost Recovery Requests) for Investigational New Drugs and Investigational Devices |
| 09/02/2026 | August 19, 2026 Summary Basis for Regulatory Action - GENGLYCOS |
| 08/28/2026 | SOPP 8421: Complying with Requirements under the Pediatric Research Equity Act (PREA) & Best Pharmaceuticals for Children Act (BPCA) |
| 08/28/2026 | August 5, 2026 Summary Basis for Regulatory Action - MFLUSIVA |
| 08/28/2026 | FDA Roundtable: Strengthening the Supply Chain for Blood Manufacturing
Meeting agenda updated |
| 08/27/2026 | August 27, 2026 Approval Letter - COMIRNATY |
| 08/27/2026 | August 27, 2026 Approval Letter - NUVAXOVID |
| 08/27/2026 | August 27, 2027 Approval Letter - SPIKEVAX |
| 08/27/2026 | August 27, 2026 Approval Letter - MNEXSPIKE |
| 08/27/2026 | August 26, 2026 - Approval Letter - DAPTACEL |
| 08/27/2026 | FDA Roundtable: Strengthening the Supply Chain for Blood Manufacturing
Updated |
| 08/27/2026 | August 26, 2026 - Approval Letter - TENIVAC |
| 08/27/2026 | August 26, 2026 - Approval Letter - Adacel |
| 08/26/2026 | FDA Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics
Updated |
| 08/26/2026 | Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry
Comment Period Open Through September 1, 2026 |
| 08/26/2026 | Potency Assessment of Active Immunotherapy Products; Draft Guidance of Industry
Comment Period Open Through November 18, 2026 |
| 08/21/2026 | BK251307- Donor Information System Version 9.0 |
| 08/21/2026 | BK251308- Biowy Multi-Chamber Freezing Bag |
| 08/21/2026 | SOPP 8005: Formal Dispute Resolution Process |
| 08/20/2026 | August 19, 2026 Approval Letter - GENGLYCOS |
| 08/19/2026 | April 29, 2026 Clinical and Clinical Pharmacology Review Memo - ASCENIV |
| 08/19/2026 | Statistical Review - ASCENIV (125590/190) |
| 08/19/2026 | August 4, 2026 Approval Letter - ELEVIDYS |
| 08/19/2026 | Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products; Guidance for Industry |
| 08/18/2026 | June 18, 2026 Clinical Review Memo - CAPVAXIVE |
| 08/18/2026 | June 18, 2026 Statistical Review Memo - CAPVAXIVE |
| 08/18/2026 | August 14, 2026 Approval Letter - DUCORD |
| 08/18/2026 | FDA Roundtable: Strengthening the Supply Chain for Blood Manufacturing
Draft agenda added |
| 08/18/2026 | June 29, 2026 Summary Basis for Regulatory Action - EZPLAZ |
