FDA News and Views: FDARA, FDA Import Decisions
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
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