February 22, 2018
- Manual of Policies and Procedures (MAPP) 7610.3 CDER Division IT Coordinator Services (PDF - 286KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Trials Snapshot: BIKTARVY
- FDA Drug Safety Communication: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
- Expanded Access INDs and Protocols (updated)
- Public Meetings: Enhanced Drug Distribution Security under the Drug Supply Chain Security Act (updated)
- OPDP Regulatory Information (updated)
- PDUFA VI Information Technology Goals and Progress (updated)
- Office of Program and Strategic Analysis (OPSA) (updated)
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