The Next Step In FDA Reform? Consolidated Drug/Device Groups Proposed By FOCR
This article was originally published in RPM Report
A Friends of Cancer Research proposal to create FDA drug-device review teams in oncology, cardiology and neurodegenerative disease could find a home in the next round of FDA reform legislation. PDUFA VI. Current and former agency officials are cautiously optimistic about the idea, but combining review operations with different statutory underpinnings will be challenging.
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FDA would be directed to test the concept of joint drug/device/diagnostic reviews in at least one therapeutic area; idea of further integrating medical product reviews is also part of Vice President’s cancer 'moonshot.'
FDA would be directed to test the concept of joint drug/device/diagnostic reviews in at least one therapeutic area under legislation proposed in the Senate. The idea of further integrating medical product reviews is already part of the Vice President’s cancer “moonshot.”