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:
- 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)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Guidance for Industry:
- National Drug Code Directory (updated)
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