CDER New March 28, 2018

March 27, 2018

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated) 
• Drugs@FDA Data Files (updated)
• Product Specific Guidance: Doxycycline hyclate (PDF - 54KB)
• Manual of Policies and Procedures (MAPP) 6010.5 NDA's and BLA's: Filing Review Issues
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• Written Requests Issued (updated)
• Pediatric Exclusivity Statistics (updated) 
• Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (updated)
• Tools to Keep You Informed (updated)