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.
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Will Senate User-Fee Package Be Smooth Sailing Despite Add-Ons?
The Senate HELP Committee is ready to mark up user-fee reauthorization legislation May 10 that includes several device add-ons to the core industry-FDA agreement. Most of the additional reforms are supported by industry, but staffers have warned that putting too much extra legislative baggage into the user-fee package could slow it down. Reforms included address device facility inspections, device accessories' classification and post-market surveillance, among other issues.
The Patient Perspective: Upcoming US FDA Device Center Studies Put Device-Users In Front Seat
A patient's point of view is paramount as the Center for Devices and Radiological Health embarks on a plan to conduct patient-perspective studies to ascertain what device-users want and value when it comes to health care. But don't call it a "survey" – "this is real research," CDRH compliance chief Robin Newman says.
Senate, House Panels Release Clean Device User-Fee Discussion Draft
Lawmakers emphasized the need for a swift reauthorization of a combined US FDA device and drug user-fee reauthorization bill before the end of July, and released a clean discussion draft April 14 that mirrors the agreements reached by industry and the agency last summer.