FDA is holding a meeting Sept. 14 to start a public dialogue on the next reauthorization of medical device user fees, more than two years before Congress needs to renew the program.
Article preview from "The Gray Sheet" - August 16, 2010
The early-on public meeting is a new requirement, mandated by Congress in the prior user fee reauthorization legislation to shed light on what some viewed as a shrouded process between companies and the agency that led to provisions in the 2007 bill.
This time around, FDA must request comments in a Federal Register notice and hold a meeting so stakeholders can weigh in on the user fee program and suggest changes before talks with industry begin.
Patient, Consumer Advocates Get More Face Time
Once negotiations start, FDA is also required to hold monthly
discussions with patient and consumer advocacy groups to gain
additional input.
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