CDER New August 31, 2016

What's New on the FDA Drugs Site

August 30, 2016

• FDA approves Erelzi, a biosimilar to Enbrel
• FDA Drug Shortages
  • Reserpine Tablets (Updated - Discontinuation)
  • Triamcinolone Hexacetonide Injectable Suspension (Aristospan) (Updated - Discontinuation)
• Public Notification: Kopi Jantan Tradisional Natural Herbs Coffee contains hidden drug ingredient
• Impax Laboratories, Inc. Issues Voluntary, Nationwide Recall for One Lot of Lamotrigine Orally Disintegrating Tablet 200 mg Due to the Potential for 100 mg Blister Cards being Packaged in 200 mg Containers
• Presentations:
  • Current Expectations and Guidance, including Data Integrity and Compliance with CGMP (PDF -  445KB)
  • Managing Risk to Quality: the Good and the Bad (PDF - 1.7MB)
  • The Importance of Assuring Quality Throughout the Lifecycle (PDF - 1MB)