CDER New July 1, 2016

What's New on the FDA Drugs Site

June 30, 2016

• Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between January - March 2016
• Public Notification: My Steel Woody contains hidden drug ingredient
• FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files
• Manual of Policies and Procedures (MAPP) 4640.2 Internal Organizational Charts (PDF - 130KB)
• Elemental Impurities in Drug Products Guidance for Industry (PDF - 100KB)
• Vulvovaginal Candidiasis: Developing Drugs for Treatment Guidance for Industry (PDF - 164KB)
• Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention Guidance for Industry (PDF - 453KB)
• Product-Specific Recommendations for Generic Drug Development. Paliperidone Palmitate (PDF - 35KB) Revised