CDER New May 20, 2013

What's New on the FDA Drugs Site
May 17, 2013

• Current Drug Shortages Index (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• MedWatch Safety Alert: Compounded Prescription Therapies By Pentec Health Inc.: Recall - Lack Of Sterility AssuranceNational 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 - 552KB)
  • Orange Book Search (updated)
• Presentations:
  • Challenges of Globalization (PDF - 834KB)
  • Adverse Event Reporting and Medication Safety Considerations: A View from CDER’s Office of Surveillance and Epidemiology (PDF - 445KB)
  • FDA Perspective: Transformational Initiatives (PDF - 252KB)
  • The Regulatory Pathway for Rare Diseases Lessons Learned from Examples of Clinical Study Designs for Small Populations (PDF - 832KB)
  • The Value of A Qualified Outcome Measure (PDF - 41KB)
• Spanish Drug Safety Communication: Zolpidem: La FDA aprueba cambios de etiqueta para los productos con zolpidem, que incluyen nueva dosificación y una recomendación de evitar conducir el día posterior al uso de Ambien CR