What's New on the FDA Drugs Site
July 7, 2016
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA issues proposals to implement statutory restrictions on compounding drugs that are essentially copies of commercially available or approved drugs
- Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 108KB)
- Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 348KB)
- Generic Drug User Fee Amendments (GDUFA) Reauthorization Stakeholder Meetings (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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