What's New on the FDA Drugs Site
May 10, 2016
- Drug Approval Package: Defitelio Injection
- FDA announces Pharmakon Pharmaceuticals’ nationwide voluntary recall of purportedly sterile drug products (updated)
- FDA Drug Safety Communication: FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax)
- Frequently Asked Questions: June 10, 2016 Public Meeting on OTC Monograph User Fees
- Public Meeting: Over-the-Counter Monograph User Fees
- Manual of Policies and Procedures (MAPP) CDER Liaisons to Official Compendia and Standards Development Organizations – Selection Process, Roles, and Responsibilities (PDF - 76KB)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- National Drug Code Directory
- Warning Letters 2016 (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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