Drugs@FDA Data Files

Published on February 18, 2025

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

Continue reading on website
Other news

Vaccines Licensed for Use in the United States

February 18, 2025
The product name and trade name of vaccines licensed for use in the United States.

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