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)
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