What's New Related to Drugs

October 29, 2019

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Delafloxacin Injection and Oral Products
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Calcium Chloride Injection, USP (New - Currently in Shortage)
  • Pantoprazole Sodium for Injection (New - Currently in Shortage)
  • Trifluridine Ophthalmic Solution (New - Currently in Shortage)
• Providing Regulatory Submissions in Electronic Format: IND Safety Reports: Guidance for Industry
• Electronic Submission of IND Safety Reports Technical Conformance Guide
• Report | Drug Shortages: Root Causes and Potential Solutions 
• National Drug Code Directory (updated)
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• FDA Adverse Event Reporting System (FAERS) Electronic Submissions (updated)