What's New Related to Drugs

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)