CDER New September 5, 2018

September 4, 2018

• Drug Trial Snapshot: ONPATTRO
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drugs@FDA Data Files (updated)
• National Drug Code Directory (updated)
• Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry (PDF - 87KB)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)