User Fee Negotiations: Should Consumer Stakeholders Sit At Table With Industry, FDA?
While FDA provided unprecedented access during PDUFA V talks, groups still want to help negotiate, which an expert thinks would irk industry.
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Anticipated legislation from Sen. Kay Hagan would copy federal regulations outlining accelerated approval to Food, Drug and Cosmetic Act, also encourage use of more broadly effective processes for expedited reviews.
Rep. Burgess says there appears to be enough bipartisan support for dealing with the shortage problem that it almost certainly will be added to the reauthorizing legislation.
FDA and industry have reached agreement on four issues in the Prescription Drug User Fee Act reauthorization, including adjustments to risk-benefit policy and creation of a meta-analysis team.