Safety & Availability (Biologics)

Published on February 18, 2025

Important information about the safety and availability of biological products.

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Biologics PREA Reviews and Labeling Changes

February 18, 2025
PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under

eSubmitter Application History

February 19, 2025
History of all updates to the application software in reverse chronological order by version number