CDER New August 22, 2017

What's New on the FDA Drugs Site

August 21, 2017

• FDA warns consumers about health risks of herbal coffee products from Malaysia containing undeclared active pharmaceutical ingredients and milk
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Pediatric Exclusivity Granted (updated)
• President signs the FDA Reauthorization Act of 2017:
  Law revises, reauthorizes Agency’s user-fee programs for medical products 
• Drug Approval Package:  
  • Nerlynx (neratinib maleate) Tablets
  • TREMFYA (guselkumab) Injection
• Medication Guides Page (Update)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)