CDER New August 17, 2015

What's New on the FDA Drugs Site

August 14, 2015

• CDER Conversation: Pediatric pain management options 
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Guidance for Industry:
  • Qualification of Biomarker Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease Draft Guidance for Industry (PDF - 154KB)
  • Botanical Drug Development: Guidance for Industry (PDF - 228KB)
  • Rare Diseases: Common Issues in Drug Development Guidance for Industry (PDF - 306KB)
• National Drug Code Directory
• Orange Book (updated)
  
  • Additions/Deletions for Prescription and OTC Drug Product Lists 
  • Orange Book Current Cumulative Supplement (PDF - 1MB) 
  • Orange Book Data Files (compressed) (ZIP - 605KB) 
• Suitability Petitions (updated)