US FDA Tries To Shape The Accelerated Approval Reform Narrative

Indicating that failure should be expected may be a subtle reminder of the potential consequences of placing more guardrails on the expedited approval pathway.

uncertainty
Industry and patient advocates also argue in favor of accelerated approval's ability to provide earlier access to drugs for diseases with unmet needs. • Source: Alamy

US Food and Drug Administration officials appear to want stakeholders, and maybe more importantly, lawmakers, to let go of the notion that failure is not an option with accelerated approval.

“There is going to be uncertainty regarding whether the drug will actually impact a clinical outcome at the time of...

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