When the head of the US Food and Drug Administration’s device center came to Capitol Hill on 30 March to discuss the renegotiated user-fee agreement between the FDA and industry, the usual questions about agency policies and priorities were laced with frustration about the FDA’s management of the process.
“By statute, as part of the MDUFA reauthorization, FDA is mandated to consult with regulated industry, patient and consumer representatives, and health care professionals, receive public comment, and submit recommendations...
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