MDUFA IV: Shorter Review Times, More Consistency, and More Oversight
TBMG-26070
12/01/2016
- Content
The reauthorization of the Medical Device User Fee Amendments (MDUFA) brings more pressure for FDA to shorten its review times back to “historical norms” and to provide more consistency in the review process. And after the success of an independent review authorized in MDUFA III in 2012, MDUFA IV has authorized two independent reviews of the agency over the next five years. Total funding for the five-year agreement is $999.5 million.
- Citation
- "MDUFA IV: Shorter Review Times, More Consistency, and More Oversight," Mobility Engineering, December 1, 2016.