MDUFA IV: Shorter Review Times, More Consistency, and More Oversight

TBMG-26070

12/01/2016

Abstract
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.

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Citation
"MDUFA IV: Shorter Review Times, More Consistency, and More Oversight," Mobility Engineering, December 1, 2016.
Additional Details
Publisher
Published
Dec 1, 2016
Product Code
TBMG-26070
Content Type
Magazine Article
Language
English