What's New on the FDA Drugs Site
March 11, 2016
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA expands use of Xalkori to treat rare form of advanced non-small cell lung cancer
- FDA Drug Shortages
- Dexamethasone Sodium Phosphate Injection (New - Currently in Shortage)
- Didanosine Delayed-Release Capsules USP (New - Discontinuation)
- Telithromycin (Ketek) Tablets (New - Discontinuation)
- Tretinoin Capsules (Updated - Currently in Shortage)
- GDUFA Reauthorization Stakeholder Meetings (updated)
- Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 Guidance for Industry (PDF - 201KB)
- Manual of Policies and Procedures (MAPP) 5240.3 Rev.2 Prioritization of the Review of Original ANDAs, Amendments, and Supplements (PDF - 280KB)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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