CDER New July 25, 2017

What's New on the FDA Drugs Site

July 24, 2017

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshot: NERLYNX
• FDA Drug Shortages
  • Acitretin (Soriatane) Capsules (New - Discontinuation)
  • Cefuroxime Axetil (Ceftin) Oral Suspension (New - Discontinuation)
  • Cytarabine Liposome (DepoCyt) Injection (New - Discontinuation)
  • Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (New - Currently in Shortage)
• ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents
  • Q3C — Tables and List Guidance for Industry
  • Maintenance Procedure for Q3C 
  • PDE FOR TRIETHYLAMINE AND METHYLISOBUTYLKETONE
• M4E(R2): The CTD — Efficacy Guidance for Industry
• National Drug Code Directory
• Compounding: Inspections, Recalls, and other Actions (updated)
• Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)