What's New on the FDA Drugs Site
May 5, 2015
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Guidance for Industry:
- Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System Guidance for Industry (PDF - 141KB)
- Providing Regulatory Submissions in Electronic Format —Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry (PDF - 111KB)
- National Drug Code Directory
- Product-Specific Recommendations for Generic Drug Development: Clozapine (PDF -22KB)
- Teva Parenteral Medicines Initiates Voluntary Nationwide Recall of Select Lots of Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL) Due to Particulate Matter
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