Device User-Fee Agreement Gets A Senate Hearing
US FDA user-fee reauthorization agreements, including the medical device MDUFA IV package, will be dissected at a Senate Health, Education, Labor, and Pensions (HELP) Committee hearing on March 21.
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FDA Passes The Buck On LDTs, But Floats Ideas
The US agency has backed away from its intent to oversee laboratory-developed tests as set out in a controversial 2014 draft guidance. Instead, in a new discussion paper it is advising legislation to handle the issue. The agency also urges LDT developers to consider recommendations to increase transparency.
MDUFA IV Takes Shape: A Catalogue Of Draft Commitments
More specific details have emerged about the agreement "in principle" announced last week by FDA and industry negotiators on the next round of the medical device user-fee program, which will extend from fiscal years 2018 through 2022.
Industry, US FDA Strike $1Bn Deal After Contentious User-Fee Negotiations
FDA and industry have finally struck a tentative deal that, with Congressional approval, aims to raise nearly a billion dollars over five years. It also holds FDA to higher quality metrics while starting a pilot project to use real-world evidence in tracking devices on the market.