January 28, 2026 at 03:55PM A Special Year, New Seal, and Renewed Commitment to the American People

The FDA has unveiled an official agency seal which signifies the many public health strides made over 120 years.

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Monday, January 26, 2026

January 26, 2026 at 04:08PM Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations

This is the draft guidance Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations

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January 26, 2026 at 03:46PM FluMist Quadrivalent

For active immunization of individuals 2 through 49 years of age for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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Friday, January 23, 2026

January 23, 2026 at 07:08PM Real-World Evidence

Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making.

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January 21, 2026 at 08:23PM CBER 2025 Orphan Approvals (new BLAs)

CBER 2025 Orphan Approvals (new BLAs)

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January 16, 2026 at 05:20PM 2025 Biological License Application Supplement Noteworthy Approvals

Listing of the 2025 Biological License Application Supplement Noteworthy Approvals

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January 16, 2026 at 04:32PM eSubmitter Application History

History of all updates to the application software in reverse chronological order by version number

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