CDER New August 19, 2015

What's New on the FDA Drugs Site

August 18, 2015

• CDER Alert: FDA warns health care professionals not to use compounded drugs stored in Becton-Dickinson (BD) 3 milliliter (ml) and 5 ml syringes
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Press Release: FDA approves first treatment for sexual desire disorder
• Hartley Medical Issues Voluntary Recall of Prolotherapy with Phenol Due to Non-sterility Concerns
• Manual of Policies and Procedures (MAPP) Communications with Industry with respect to pre-GDUFA Year Three Abbreviated New Drug Applications (PDF – 76KB)
• National Drug Code Directory
• Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act (updated)
• Paragraph IV Patent Certifications (updated)
• Postmarket Requirements and Commitments Search (updated)
• Postmarket Requirements and Commitments Download (updated)