CDER New August 12, 2015

What's New on the FDA Drugs Site

August 11, 2015

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files (updated)
• First-Time Generic Drug Approvals – July 2015 (updated)
• Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 75KB)
• National Drug Code Directory
• Phonetic and Orthographic Computer Analysis (POCA) program (updated)
• Priority Therapeutic Areas for Development (updated)
• Warning Letters 2015 (updated)