April 19, 2018
- Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act (updated)
- Spectrum of Diseases/Conditions (updated)
- Pediatric Exclusivity Statistics (updated)
- Written Requests Issued (updated)
- CDER Warning Letters 2018 (updated)
- FDA Drug Shortages
- Potassium Chloride Injection (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Discontinuation)
- Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers Guidance for Industry (PDF - 218KB)
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