CDER New: 9/11/2020

What's New Related to Drugs

Updated Monday through Friday:

• Drug Firm Annual Registration Status
• Drug Firm Annual Registration Status Download File
• National Drug Code Directory
• NDC Unfinished Drugs Excluded Database File
• NDC Database Excluded Packages and Products
• Wholesale Distributor and Third-Party Logistics Providers Reporting

• September 10, 2020
  
  • Guidance for Industry: Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency
  • CDER Warning Letters 2020 (updated)
  • Drug Trials Snapshots: DETECTNET
  • FDA Drug Shortages
    • Bumetanide Injection, USP (Updated - Currently in Shortage)
    • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
    • Calcium Chloride Injection, USP (Updated - Currently in Shortage)
    • Cisatracurium Besylate Injection (Updated - Currently in Shortage)
    • Dexmedetomidine Injection (Updated - Currently in Shortage)
    • Dextrose 25% Injection (Updated - Currently in Shortage)
    • Dextrose 50% Injection (Updated - Currently in Shortage)
    • Diltiazem Hydrochloride (Updated - Currently in Shortage)
    • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
    • Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
    • Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
    • Etomidate Injection (Updated - Currently in Shortage)
    • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
    • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
    • Hydrocortisone Tablets, USP (Updated - Currently in Shortage)
    • Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
    • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
    • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
    • Lorazepam Injection, USP (Updated - Currently in Shortage)
    • Metoprolol Tartrate Injection, USP (Updated - Currently in Shortage)
    • Midazolam Injection, USP (Updated - Currently in Shortage)
    • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
    • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
    • Propofol Injectable Emulsion (Updated - Currently in Shortage)
    • Sulfasalazine Tablets (Updated - Currently in Shortage)
    • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
  • SBIA Webinar: Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs - October 2, 2020