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MDUFA V: FDA Proposes New Program To Engage External Experts Early – But Industry’s Skeptical

The US agency is asking medtech companies to fund a program that would bring together external experts to advise on their products early on, but industry is skeptical about the program’s ability.

A closeup portrait of a Caucasian skeptical man with his hand on his chin

The US Food and Drug Administration has proposed raising more funds through device user fees that would fund earlier interactions with companies looking to get their product on the market. Industry, however, doesn’t want to increase user-fee revenues and is skeptical of the idea.

The FDA published on 16 June meeting minutes from its 7 April negotiations with industry representatives over the next...

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