CDER New November 28, 2017

November 27, 2017

• CDER Conversation: The FDA’s Sentinel Initiative
• Drug Approval Package:
  • FYCOMPA (perampanel) Oral Suspension
  • VEMLIDY (tenofovir alafenamide) Tablet
  • Xultophy 100/3.6 (insulin degludec and liraglutide) Injection
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA introduces patent submission date updates to the Orange Book (updated)
• Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF - 393KB)
• National Drug Code Directory (updated)
• New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products (updated)
• Sun Pharmaceutical Industries Inc. Issues Voluntary Nationwide Recall of Riomet (Metformin Hydrochloride Oral Solution) Manufactured by a Contract Manufacturer due to Microbial Contamination
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)