CDER New January 26, 2017

What's New on the FDA Drugs Site

 January 25, 2017

• Drug Safety and Risk Management Advisory Committee Roster (updated)
• Manual of Policies and Procedures (MAPP)
  • 5040.1 Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q) (PDF - 91KB)
  • 5310.7 Acceptability of Standards from Alternative Compendia (BP/EP/JP) (PDF - 66KB)
• Data Standards in the Drug Lifecycle—updates include the Interactive “Data Standards in the Drug Lifecycle” Infographic  
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated) 
• Drugs@FDA Data Files (updated)
• FDA MedWatch - Vancomycin Hydrochloride for Injection, USP by Hospira: Recall - Particulate Matter in Vial
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• Registration Now Open: FDA and USP Workshop on Standards for Pharmaceutical Products FDA and USP Workshop on Standards for Pharmaceutical Products - Critical Importance of Excipients in Product
  Development – Why Excipients are Important Now and In the Future (February 27 - 28, 2017)