CDER New June 6, 2017

What's New on the FDA Drugs Site

June 5, 2017

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Paragraph IV Patent Certifications (PDF - 429KB)
• Drug Approval Package
  • RYDAPT (midostaurin) Capsules
• National Drug Code Directory: Download the New NDC Express Mobile Application
• Presentation: Current Expectations and Guidance, Including Data Integrity and Compliance with CGMP (PDF - 796KB)
• FDA-ASCO: Hematology and Oncology Fellows Day Workshp, September 15, 2017
• Pulmonary-Allergy Drugs Advisory Committee Roster (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)