CDER New May 31, 2017

What's New on the FDA Drugs Site

May 30, 2017

• FDA D.I.S.C.O.: First Tissue/Site Agnostic Approval Transcript
• Activities Report of the Generic Drug Program (FY 2017) (updated)
• FDA Leads Effort to Create a Supply Chain Security Toolkit for Medical Products
• Drug Approval Packages
  
  • Alunbrig (brigatinib) Tablets
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Lupin Pharmaceuticals Inc. Announces a Nationwide Recall of Mibelas 24 Fe (Norethindrone Acetate and EthinyEstradiol 1mg/0.02mg Chewable Tablets and Ferrous Fumarate 75 mg) Tablets Due to Out of Sequence Tablets and Missing Expiry/Lot Information
• Manual of Policies and Procedures (MAPP) 4658.4 CDER FTE Tracking and Table of Organization Review Process(PDF - 271KB)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)