CDER New August 28, 2015

What's New on the FDA Drugs Site

August 27, 2015

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Safety Communication: FDA warns of severe adverse events with application of Picato (ingenol mebutate) gel for skin condition; requires label changes (updated)
• FDA Drug Shortages
  • L-Cysteine Hydrochloride Injection   (Updated - Currently in Shortage)
  • Reserpine Tablets   (Updated - Currently in Shortage)
• FDA Voice Blog: Naming and Biological Products
• National Drug Code Directory
• Nonproprietary Naming of Biological Products Guidance for Industry (PDF - 111KB) 
  FR Notice of Availability: Guidance: Nonproprietary Naming of Biological Products; 
  FR  Proposed Rule: Designation of Official Names and Proper Names for Certain Biological Products