CDER New September 6, 2018

September 5, 2018

• Manual of Policies and Procedures (MAPP)
  • 5014.1 Understanding CDER’s Risk-Based Site Selection Model (PDF - 83KB)
  • 7500.1Rev. 2 Regulatory Project Management Coordinating Committee (PDF - 91KB)
  •  6025.4 Good Review Practice: Refuse to File (PDF - 270KB)
  •  6030.3 Emergency Investigational New Drug Application Process During and After Normal Business Hours (PDF - 219KB)
• FDA Drug Shortages
  • Diltiazem Hydrochloride (Updated - Currently in Shortage)
  • Meropenem for Injection, USP (New - Discontinuation)