What's New on the FDA Drugs Site
January 17, 2017
- CDER Drug Statement: FDA approves a generic of Xyrem with a REMS Program
- 2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry (PDF - 82KB)
- FDA Drug Shortages
- Alitretinoin (Panretin) Gel (New - Currently in Shortage)
- Cefepime Injection (New - Currently in Shortage)
- Tobramycin Injection (Updated - Currently in Shortage)
- From our perspective: Interchangeable biological products
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Timolol GFS 0.25% and 0.5%: Clinical Review (PDF - 775KB) and Written Request (PDF -110KB)
- Assessment of Abuse Potential of Drugs Guidance for Industry (PDF - 285KB)
- Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry (PDF - 229KB)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers Guidance for Industry (PDF - 134KB)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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