May 9, 2018
- Director's Corner Podcasts: Breakthrough Therapy Designation mp3
- Director's Corner Podcasts: Breakthrough Therapy Designation - Transcript
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages
- Azithromycin (Azasite) Ophthalmic Solution 1% (New - Currently in Shortage)
- Cefepime Injection (Updated - Currently in Shortage)
- Dexrazoxane Injection (Updated - Currently in Shortage)
- Didanosine Delayed-Release Capsules USP (New - Discontinuation)
- Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage)
- Epinephrine Injection, Auto-Injector (New - Currently in Shortage)
- EpiPen® Auto-Injector and Epinephrine Injection, USP Auto-Injector (New - Currently in Shortage)
- S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling Questions and Answers Guidance for Industry (PDF - 149KB)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
- Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for Industry (PDF - 125KB)
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