CDER New June 8, 2018

June 7, 2018

• OGD PSA Radio Ad - Safe and Effective - 15 seconds - Transcript
• OGD PSA Radio Ad - Safe and Effective - 15 seconds - Audio
• OGD PSA Radio Ad - Safe and Effective - 30 seconds - Transcript
• OGD PSA Radio Ad - Safe and Effective - 30 seconds - Audio
• OGD PSA Radio Ad - Safe and Effective - Spanish version - 30 seconds - Transcript
• OGD PSA Radio Ad - Safe and Effective - Spanish version - 30 seconds - Audio
• Manual of Policies and Procedures (MAPP) 7412.2 Rev 1 Management of CDER Carcinogenicity Assessment Committee and Communication of Committee Proceedings (PDF - 77KB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated) 
• Drug Approval Packages: 
  • Austedo (deutetrabenazine) Tablets   
  • Daptomycin for Injection
  • Photrexa  
  • Voriconazole for Injection  
• Drug Trials Snapshots: LUCEMYRA
• Drug Trial Snapshots:  DOPTELET
• FDA Drug Shortages
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
• Public Notification: PAYA Dietary Supplement Product contains hidden drug ingredient
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)