CDER New January 14, 2016

What's New on the FDA Drugs Site

January 13, 2016

• CDER Conversation: FDA’s Clinical Outcome Assessment Compendium
• CDERLearn Online Courses
  • GDUFA Self-Identification (SPL) Submission – Part 1
  • GDUFA Self-Identification (SPL) Submission – Part 2
  • Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA)
• Clinical Outcome Assessment Compendium
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshots: EMPLICITI
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Haloperidol Lactate Injection (Updated - Currently in Shortage)
• National Drug Code Directory
• Paragraph IV Patent Certifications (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)