CDER New July 5, 2018

July 3, 2018

• Abbreviated New Drug Application Submissions--Amendments to Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Guidance for Industry (PDF - 219KB)
• Bioresearch Monitoring Information System (BMIS) 
• Clinical Investigator Inspection List (CLIIL)
• Drugs@FDA Data Files (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Approval Packages: 
  • Zelboraf (vemurafenib)   
  • ZERVIATE (cetirizine ophthalmic solution)
• National Drug Code Directory (Updated - Currently in Shortage)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)