What's New on the FDA Drugs Site
September 8, 2016
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies – Questions and Answers (PDF - 181KB)
- E17 General Principles for Planning and Design of Multi-Regional Clinical Trials Guidance for Industry (PDF - 359KB)
- FDA Drug Shortages
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Currently in Shortage)
- Sodium Acetate Injection, USP (Updated - Currently in Shortage)
- Vancomycin Hydrochloride for Injection, USP (Updated - Currently in Shortage)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
- United Exchange Corp. Issues Voluntary Nationwide Recall of Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories Due to Microbial Contamination
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