February 21, 2018
- Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry (PDF - 110KB)
- BIORESEARCH MONITORING TECHNICAL CONFORMANCE GUIDE (PDF - 697KB)
- Drug Approval Packages:
- FDA Drug Shortages
- Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)
- Atenolol Tablets (Updated - Currently in Shortage)
- Diltiazem Hydrochloride (New - Currently in Shortage)
- Dorzolamide Hydrochloride and Timolol Maleate (Cosopt) Ophthalmic Solution (Updated - Currently in Shortage)
- Dorzolamide Hydrochloride Ophthalmic Solution (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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