September 27, 2017
- Manual of Policies and Procedures (MAPP) 5015.12 Process for Evaluating Emerging Technologies Related to Quality (PDF - 83KB)
- Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry (PDF - 122KB)
- Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry (PDF - 71KB)
- Drug Approval Package
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Patent Certifications and Suitability Petitions (updated)
- Drug Trials Snapshots: ALIQOPA
- FDA Drug Shortages
- Carbidopa and Levodopa Extended Release Tablets (New - Currently in Shortage)
- Manual of Policies and Procedures (MAPP) 6004.2 Rev.2 Procedures for Completing and Processing the Form "Annual Status Report Review Form: PMR and PMC Summary" (PDF - 120KB)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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