May 30, 2025 at 08:33PM Ongoing | Infectious Disease Accelerated Approvals Vaccines

Biologic Accelerated Approvals Based on a Surrogate Endpoint

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May 30, 2025 at 03:43PM Devices Guidances

This page lists Medical Device Guidance documents.

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Thursday, May 29, 2025

May 29, 2025 at 10:20PM CBER Rare Disease Program 

Description of CBER's Rare Disease Program, including a description of the program, selected activities, examples of collaborations internal and external to CBER, and frequently asked questions.

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May 22, 2025 at 11:16PM COVID-19 Vaccines (2025-2026 Formula) for Use in the United States Beginning in Fall 2025

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on May 22, 2025, to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the United States beginning in the fall of 2025.

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May 22, 2025 at 11:08PM Flublok Quadrivalent

Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older.

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May 22, 2025 at 01:19PM Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

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Tuesday, May 20, 2025

May 20, 2025 at 03:20PM Supreme Rejuvenation, LLC - 700749 - 05/05/2025

Unapproved New Drugs/Misbranded

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May 14, 2025 at 12:05PM JYNNEOS

Indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.


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