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June 28, 2024

Written Requests Issued

Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act NOTE: This list simply identifies […]
June 28, 2024

Industry Frequently Asked Questions

Below are frequently asked questions and the associated answers sorted by topic area.  Drug Review What information and types of notifications are provided to sponsors during […]
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