| 08/27/2026 | August 27, 2026 Approval Letter - COMIRNATY |
| 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08/26/2026 | Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry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| 08/26/2026 | Potency Assessment of Active Immunotherapy Products; Draft Guidance of Industry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 |
| 08/14/2026 | Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions |
| 08/13/2026 | Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry |
| 08/13/2026 | August 6, 2026 Summary Basis for Regulatory Action - TUDRIQEV |
| 08/12/2026 | Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Guidance for Industry |
| 08/10/2026 | August 7, 2026 Approval Letter - MRESVIA |
| 08/07/2026 | August 6, 2026 Approval Letter - YESCARTA |
| 08/06/2026 | August 6, 2026 Approval Letter - TUDRIQEV |
| 08/06/2026 | August 5, 2026 Approval Letter - MFLUSIVA |
| 08/06/2026 | FDA Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics
Draft agenda added |
| 08/03/2026 | Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance of Industry
Updated: August 3, 2026 |
| 7/31/2026 | July 31, 2026 Approval Letter - Alphanate |
| 7/31/2026 | July 30, 2026 Approval Letter - ADACEL |
| 07/31/2026 | Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry |
| 07/30/2026 | SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA) |
| 07/29/2026 | July 29, 2026 Approval Letter - EZPLAZ |
| 07/28/2026 | July 27, 2026 Approval Letter - AREXVY |
| 07/27/2026 | Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, IRBs, and Clinical Investigators |
| 07/27/2026 | Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, IRBs, and Clinical Investigators |
| 07/27/2026 | Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, IRBs, and Clinical Investigators |
| 07/24/2026 | BK261351- ADAMII CD34 System |
| 07/23/2026 | OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products
Town Hall Transcript available |
| 07/23/2026 | July 22, 2026 Approval Letter - FluMist |
| 07/16/2026 | SOPP 8795: Posting and Announcement of Premarket Approval Application and Humanitarian Device Exemption Approvals and Denials |
| 07/15/2026 | July 14, 2026 Approval Letter - HEXTEND HMW Hydroxyethel Starch (6%) |
| 07/15/2026 | FDA Roundtable: Strengthening the Supply Chain for Blood Manufacturing
Date: September 29, 2026 |
