CDER New June 28, 2017

What's New on the FDA Drugs Site

June 27, 2017

• Paragraph IV Patent Certifications (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Tackles Drug Competition to Improve Patient Access
• Manual of Policies and Procedures (MAPP) 5240.3 Rev. 3 Prioritization of the Review of Original ANDAs, Amendments, and Supplements (PDF - 107KB)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act of 2012 (FDASIA) (updated)