CDER New May 9, 2013

What's New on the FDA Drugs Site
May 8, 2013

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• FDA Press Release: FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop
• Guidance for Industry:
  • Charging for Investigational Drugs Under an IND — Qs & As (PDF - 57KB)
  • Expanded Access to Investigational Drugs for Treatment Use — Qs & As (PDF -75KB)