CDER New February 1, 2016

What's New on the FDA Drugs Site

January 29, 2016

• Drug Trials Snapshot: NINLARO
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshots: Portrazza
• FDA approves Zepatier (elbasvir and grazoprevir) for treatment of chronic hepatitis C genotypes 1 and 4
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• National Drug Code Directory
• Orange Book Annual Edition: 36th edition (PDF - 8MB) 
  
• Paragraph IV Patent Certifications (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)