FDA Asks For Input On Best Ways To Support Premarket Use Of Real-World Evidence

The US Food and Drug Administration is seeking public comment on how best to allocate funds authorized under the latest installment of the Medical Device User Fees Amendments to support premarket real-world evidence.

Real-World Data
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As the fifth reauthorization of the Medical Device User Fees Amendments (MDUFA V) rolls out, the Food and Drug Administration announced it is seeking public comment on how the agency can enhance medical device performance.

Under MDUFA V, which went into effect 1 October, a portion of user fees is allocated to support the premarket...

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