CDER New October 22, 2015

What's New on the FDA Drugs Site

October 21, 2015

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Fluoxymesterone (Androxy) Tablets, USP (Updated - Resolved)
  • Formoterol Fumarate (FORADIL® AEROLIZER®) Inhalation Powder (New - Discontinuation)
  • Mometasone Furoate Monohydrate (Nasonex) (Updated - Resolved)
• Guidance for Industry:
  • Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use (PDF - 113KB)
• National Drug Code Directory
• Public Webinar: Health Canada and United States Food and Drug Administration - Joint Public Consultation on International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, November 12, 2015, Webinar. Meeting information
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)