CDER New June 3, 2016

What's New on the FDA Drugs Site

June 2, 2016

• Expanded Access (Compassionate Use) Updated
• Single Patient Expanded Access: What You Need to Know (PDF - 1.2MB) 
• Single Patient Expanded Access: Physician Fact Sheet and Application Checklist (PDF - 795KB) 
• Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers Guidance for Industry (PDF - 180KB)
• Charging for Investigational Drugs Under an IND — Questions and Answers Guidance for Industry (PDF - 87KB)
• Individual Patient Expanded Access Applications: Form FDA 3926 Guidance for Industry (PDF - 88KB)
• E18 Genomic Sampling and Management of Genomic Data (PDF - 171KB)
• FDA approves Netspot (gallium Ga 68 dotatate injection),  a new diagnostic imaging agent to detect rare neuroendocrine tumors
• FDA Drug Safety Communication: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch
• FDA Drug Shortages
  • Lindane Lotion, USP 1% (New - Discontinuation)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)