Devices

FDA TPLC Advisory Program Proposal

At the 4/7 MDUFA 5 reauthorization meeting, FDA presented its initial proposal for a total product lifecycle (TPLC) advisory program (TAP). According to meeting minutes, the agency said the current MDUFA program has been optimizing a limited portion of the TPLC.

“By investing in earlier and more strategic coordination of stakeholder input,” FDA said, “as well as more frequent FDA interactions and faster FDA responses, FDA believes the MDUFA program can continue to help nurture the MedTech ecosystem and help ensure that U.S. patients have access to high-quality, safe, effective, and innovative medical devices first in the world for years to come.”

The proposal says the TAP is intended to enable earlier, more frequent, and more strategic communication between FDA and sponsors, as well as to facilitate sponsors’ early engagement and coordination with external stakeholders that affect patient access to medical technologies. The program would be designed to leverage scale, enhance existing FDA programs and support convening external stakeholders to provide early strategic input to sponsors, FDA said. The agency said its proposed initial targets for TAP are devices eligible for the breakthrough devices program and safer technologies program and other devices with features of public health importance, such as those targeting underserved populations.

During the session, industry presented its guiding principles for user fee reauthorization: timely patient access to safe and effective products; that congressional appropriations remain the primary source of FDA’s funding and that user fees are additive; that use of fees should be solely for the premarket review process, but that industry is willing to partner with stakeholders on additional appropriations for postmarket activities; that industry has made significant and material investments under MDUFA 1-4; and that user fees should support premarket goals and process improvements to achieve timely patient access.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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