FDA BRIEF: Week of July 31, 2017

FDA Reauthorization Act (FDARA)

Congress passed the FDA Reauthorization Act (FDARA) of 2017

  • Reauthorizes user fee programs necessary for pre-market evaluation of prescription drugs (PDUFA), medical devices (MDUFA), generic drugs (GDUFA), and biosimilar (BsUFA) products
  • Ensures continuity for medical product review programs


ACE bar graph

New System Speeds FDA Import Decisions

by: Douglas Stearn, Program Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs

Automated Commercial Environment (ACE), piloted in 2015  

  • for determining whether FDA-regulated products can enter the US
  • uses to determine the admissibility of imports
  • tools include inspections of manufacturing plants abroad, physical inspection of goods, import alerts
  • better automation of admissibility process with lower-risk products

Improvements under ACE

  • automated messages that an import “may proceed” into U.S. without manual review
  • less need to request additional information from the importers
  • improved processing times-  average within 1 minute and 36 seconds
  • improvements for products that require manual processing



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