CDER New November 20, 2015

What's New on the FDA Drugs Site

November 19, 2015

• Manual of Policies and Procedures (MAPP)  4651.3 PHS Commissioned Corps Awards (PDF - 78KB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA moves quickly to approve Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride to treat opioid overdose
• FDA working with manufacturers to resolve challenges with the Clozapine REMS Program (updated)
• Human Drug Compounding Registration And Product Reporting Procedures (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• Public Notifications: 
  • Perfect Slim Fast Track Slim contains hidden drug ingredients
  • Super Herbs contains hidden drug ingredients
  • Slyn Both contains hidden drug ingredients
  • Zero Fat contains hidden drug ingredients
  • SPCARET Princess Diet contains hidden drug ingredient
  • Rhino X contains hidden drug ingredient
  • Australia Kangaroo Essence contains hidden drug ingredient
  • Effective Viagra Tablets contain hidden drug ingredient
  • Sex Drive Capsules contain hidden drug ingredient
  • XForMan Plus contains hidden drug ingredient
• Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)