What's New on the FDA Drugs Site
September 22, 2016
- Bioresearch Monitoring Information System (BMIS) Search (updated)
- CDER SBIA Chronicles
- Clinical Investigator Inspection List (CLIIL) Search (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Self-Identification of Generic Drug Facilities, Sites, and Organizations Guidance for Industry (PDF - 82KB)
- Manual of Policies and Procedures (MAPP) 4000.4 Rev.1 Good Review Practices: Clinical Pharmacology Review of New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (PDF - 307KB)
- National Drug Code Directory
- Warning Letters 2016 (updated)
- Wells Pharmacy Network Issues Voluntary Nationwide Recall of Sterile Products due to Concern for Lack of Sterility Assurance
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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