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GOP Accelerated Approval Proposal Could Expand Eligibility For US FDA Pathway

 
• By Derrick Gingery

The rival to House Energy and Commerce Committee Chair Frank Pallone’s bill would not set expiration dates for accelerated approvals.

US Capitol
The Republican proposal would allow sponsors to create a clinical development plan with the FDA to provide more clarity and certainty. • Source: Alamy

A Republican accelerated approval reform proposal attempts to expand eligibility for the US Food and Drug Administration’s expedited pathway and eschews automatic expiration dates for product clearances.

Current law states that the FDA can approve a product using the pathway upon a determination of an effect on a surrogate endpoint reasonably likely to predict clinical benefit or a clinical endpoint that can be measured earlier than irreversible morbidity or mortality,

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