What's New Related to Drugs

Advancement of Emerging Technology Applications for Pharmaceutical Innovation and

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
  • BESPONSA
  • STERITALC
• 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)