CDER New December 28, 2015

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

Download Orange Book Express

  

What's New on the FDA Drugs Site

December 23, 2015

• Bioresearch Monitoring Information System (BMIS) Search
  More information about the database  
• Clinical Investigator Inspection List (CLIIL) Search
  More information about the database
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Draft Guidance on Pharmaceutical Quality/CMC: Draft Guidance for Industry on Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base; Draft Guidance for Industry; Availability  (PDF -  64KB)
• Drug Trials Snapshots: COTELLIC
• Drugs@FDA Data Files (updated)
• FDA approves Zurampic (lesinurad) to treat high blood uric acid levels associated with gout
• FDA Drug Shortages
  • Piperacillin and Tazobactam (Zosyn) Injection   (Updated - Currently in Shortage)
  • Tigecycline (Tygacil) Injection   (Updated - Currently in Shortage)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)