January 3, 2018
- Drug Shortage Assistance Award (updated)
- Phonetic and Orthographic Computer Analysis (POCA) program (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Montelukast Sodium Tablets (New - Discontinuation)
- Good ANDA Submission Practices Guidance for Industry (PDF - 250KB)
- Manual of Policies and Procedures (MAPP) 5241.3 Good Abbreviated New Drug Application Assessment Practices (PDF - 182KB)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
- La revisión de la FDA no encontró un incremento significativo en el riesgo de resultados graves para el asma con el uso de beta agonistas de acción prolongada (BAAP) en combinación con corticoesteroides inhalados (CEI)
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