| Closes | Document |
|---|
closed 1 day ago
Oct 16, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI
Notice · published Aug 17, 2026 · FDA-2025-E-0485, FDA-2025-E-0486, FDA-2025-E-0488, FDA-2025-E-0489, FDA-2025-E-0490
Vaccines / biologics |
closed 1 day ago
Oct 16, 2026 | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing
Notice · published Sep 16, 2026 · FDA-2026-N-0027
Vaccines / biologics |
closed 15 days ago
Oct 2, 2026 | Modification of Certain Terminology in Title 21; Reopening of the Comment Period
Proposed Rule · published Aug 3, 2026 · FDA-2026-N-2886
Clinical Vaccines / biologics Medical devices Food & dietary supplements Tobacco |
closed 15 days ago
Oct 2, 2026 | Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability
Notice · published Aug 3, 2026 · FDA-2026-D-4272
CMC (chemistry, manufacturing & controls) Vaccines / biologics Medical devices |
closed 16 days ago
Oct 1, 2026 | Electronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International Council of Harmonisation E2B(R3) Data Standards; Regional Data Elements and Implementation Schedule
Notice · published Apr 6, 2026 · FDA-2016-D-1280
CMC (chemistry, manufacturing & controls) Vaccines / biologics |
closed 25 days ago
Sep 22, 2026 | Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability
Notice · published Jun 24, 2026 · FDA-2019-D-4964
Clinical Vaccines / biologics |
closed 43 days ago
Sep 4, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications, Procedures and Requirements
Notice · published Jul 6, 2026 · FDA-2026-N-6667
Vaccines / biologics |
closed 46 days ago
Sep 1, 2026 | Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability
Notice · published Jun 3, 2026 · FDA-2026-D-1257
Vaccines / biologics |
closed 78 days ago
Jul 31, 2026 | Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability
Notice · published Jun 1, 2026 · FDA-2026-D-2839
Vaccines / biologics |
closed 85 days ago
Jul 24, 2026 | Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability
Notice · published Jun 24, 2026 · FDA-2026-D-6539
Vaccines / biologics |
closed 86 days ago
Jul 23, 2026 | Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments
Notice · published Apr 15, 2026 · FDA-2026-N-3273
Vaccines / biologics |
closed 95 days ago
Jul 14, 2026 | Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability
Notice · published Apr 15, 2026 · FDA-2026-D-1255
Clinical Vaccines / biologics |
closed 103 days ago
Jul 6, 2026 | Modification of Certain Terminology in Title 21
Proposed Rule · published May 6, 2026 · FDA-2026-N-2886
Clinical Vaccines / biologics Medical devices Food & dietary supplements Tobacco |
closed 124 days ago
Jun 15, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; UNLOXCYT
Notice · published Apr 16, 2026 · FDA-2025-E-0501, FDA-2025-E-0502
Vaccines / biologics |
closed 137 days ago
Jun 2, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; ZIIHERA
Notice · published Apr 3, 2026 · FDA-2025-E-0372
Vaccines / biologics |
closed 137 days ago
Jun 2, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY
Notice · published Apr 3, 2026 · FDA-2025-E-0845, FDA-2025-E-0863, FDA-2025-E-0864, FDA-2025-E-0865, FDA-2025-E-0866, FDA-2025-E-0867, FDA-2025-E-0868, FDA-2025-E-0869, FDA-2025-E-0870, FDA-2025-E-0871, FDA-2025-E-0872
Vaccines / biologics |
closed 137 days ago
Jun 2, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; HYMPAVZI
Notice · published Apr 3, 2026 · FDA-2025-E-0158
Vaccines / biologics |
closed 137 days ago
Jun 2, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; ENFLONSIA
Notice · published Apr 3, 2026 · FDA-2025-E-3626
Vaccines / biologics |
closed 137 days ago
Jun 2, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; ENCELTO
Notice · published Apr 3, 2026 · FDA-2025-E-1672
Vaccines / biologics |
closed 137 days ago
Jun 2, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS
Notice · published Apr 3, 2026 · FDA-2025-E-3073, FDA-2025-E-3074
Vaccines / biologics |
closed 138 days ago
Jun 1, 2026 | Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments
Notice · published Mar 31, 2026 · FDA-2026-N-2476
Clinical Vaccines / biologics |
closed 152 days ago
May 18, 2026 | Medical Devices; Radiology Devices; Classification of Blood Irradiators
Proposed Rule · published Mar 18, 2026 · FDA-2025-N-5996
Vaccines / biologics Medical devices |
closed 152 days ago
May 18, 2026 | Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis
Proposed Rule · published Mar 18, 2026 · FDA-2025-N-5995
Vaccines / biologics Medical devices |
closed 159 days ago
May 11, 2026 | New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act; Draft Guidance for Industry; Availability
Notice · published Mar 10, 2026 · FDA-2011-D-0611
Vaccines / biologics |
closed 162 days ago
May 8, 2026 | Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability
Notice · published Mar 9, 2026 · FDA-2025-D-1504
GMP / manufacturing Vaccines / biologics |
closed 173 days ago
Apr 27, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; TEVIMBRA
Notice · published Feb 26, 2026 · FDA-2024-E-3572
Vaccines / biologics |
closed 173 days ago
Apr 27, 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; Availability
Notice · published Feb 25, 2026 · FDA-2026-D-1256
Vaccines / biologics |
closed 173 days ago
Apr 27, 2026 | Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing.
Notice · published Feb 25, 2026 · FDA-2026-N-0027
Vaccines / biologics |
closed 180 days ago
Apr 20, 2026 | Determination of Regulatory Review Period for Purposes of Patent Extension; SYMVESS
Notice · published Feb 19, 2026 · FDA-2025-E-0862
Vaccines / biologics |