November 27, 2017
- CDER Conversation: The FDA’s Sentinel Initiative
- Drug Approval Package:
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA introduces patent submission date updates to the Orange Book (updated)
- Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF - 393KB)
- National Drug Code Directory (updated)
- New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products (updated)
- Sun Pharmaceutical Industries Inc. Issues Voluntary Nationwide Recall of Riomet (Metformin Hydrochloride Oral Solution) Manufactured by a Contract Manufacturer due to Microbial Contamination
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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