PMA Review Times Increased After User Fee Initiation, Study Affirms
This article was originally published in The Gray Sheet
Researchers sought to investigate the impact on market access of several health-care “modernization” laws enacted in the past 15 years, finding that legislative efforts have not improved FDA or CMS review efficiency for devices.
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The tentative agreement of $595 million in user fees over five years is more than companies had wanted to spend. But industry negotiators insist it is a good deal, tied to performance goals and process improvements they say will ensure greater speed and predictability in reaching the U.S. market.
Biogen value-based contract with UPMC Health Plan ties payments to patient-reported outcomes for Tecfidera and Avonex. The company may seek something similar for Vumerity.