CDER New February 21, 2018

February 20, 2018

• Manual of Policies and Procedures (MAPP): 6030.1 Rev.3 IND Clinical Holds (PDF - 100KB)
• 12th Annual FDA/DIA Biostatistics Industry and Regulator Forum 2018
• Drug Approval Packages: 
  • Ascor (ascorbic acid) Injection
  • Bivalirudin in 0.9% Sodium Chloride
  • Xhance (fluticasone propionate) Nasal Spray
• Drug Trials Snapshots: LUTATHERA
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage) 
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (New - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection, USP (New - Currently in Shortage)
  • Carbidopa and Levodopa Extended Release Tablets (Updated - Currently in Shortage)    
  • Ketamine Injection (New - Currently in Shortage)
  • Lidocaine Hydrochloride Injection (New - Currently in Shortage)