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Accelerated Approval Reforms Give US FDA More Power And Flexibility – With Some Gaps

 
• By Sue Sutter

Pending legislation will give agency ability to require that confirmatory studies be underway at time of approval and expedited withdrawal process could allow FDA to skip a second advisory committee meeting, but Congress holds back on some agency requests for expanded authority.

Garden path
Omnibus funding measure includes expedited withdrawal procedures aimed at creating a clearer path for the FDA to get an accelerated approval drug off the market. • Source: Shutterstock

The fiscal year 2023 US government funding bill moving through Congress this week includes accelerated approval pathway reforms aimed at giving the Food and Drug Administration more authority to ensure the timely enrollment and completion of confirmatory trials.

However, the agency would appear to have considerable discretion in deciding when to require that a confirmatory study must be...

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