U.S. Food & Drug Administration (FDA) ► CDER New December 3-6

What's New on the FDA Drugs Site

December 6, 2012

• GDUFA Backlog Arrears List (updated)
• GDUFA Self Identified Facilities List (updated)
• FDA Drug Safety Communication: Important change to heparin container labels to clearly state the total drug strength
• FDA Drug Safety Podcast: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products
• MedWatch Safety Alert: Isovue (iopamidol injection) Pre-Filled Power Injector Syringes by Bracco Diagnostics Inc.: Recall - Presence of Particulates
• Pediatric Statistics: Breakdown of FDAAA Completed Pediatric Studies (updated)
• Spanish FDA Drug Safety Communication: Zofran: Información actualizada sobre la dosis intravenosa de 32 mg de ondansetrón (Zofran) y productos previamente mezclados de ondansetrón

December 5, 2012

• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• Drugs@FDA Download File (updated)
• Guidance for Industry:
  • Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-The-Counter Human Use — Small Entity Compliance Guide
  • Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products 
• Medication Guides (updated)

December 4, 2012

• Current Drug Shortages Index (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• FDA Drug Safety Communication: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products

December 3, 2012

• Current Drug Shortages Index (updated)
  • Drugs to be Discontinued: Ondansetron Injection 32 mg/50 mL premixed bags
  • Drugs to be Discontinued: Ondansetron Injection 32 mg/50 mL premixed bags
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• Guidance for Industry:
  • Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs (PDF - 369KB)
  • FDA Oversight of PET Drug Products -- Questions and Answers (PDF - 499KB)
• National Drug Code Directory (updated)