CDER New November 16, 2015

What's New on the FDA Drugs Site

Searching the Orange Book is now faster and easier with our new mobile app!

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November 13, 2015

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshots: REPATHA
• FDA approves Tagrisso (osimertinib), a new pill to treat certain patients with non-small cell lung cancer
• FDA working with manufacturers to resolve challenges with the Clozapine REMS Program
• Guidance on Qualification of Biomarker — Galactomannan in studies of treatments of invasive Aspergillosis (PDF - 141KB)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated) 
• National Drug Code Directory
• Orange Book (updated)
  • Additions and Deletions to the Drug Product List
  • Orange Book Current Cumulative Supplement (PDF - 1014KB)
  • Orange Book Data Files (compressed) (ZIP - 614KB) 
• Paragraph IV Patent Certifications (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)