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Accelerated Approval: US FDA Should Explain Why An Ongoing Trial Is Not Required

 
• By Sue Sutter

Having a confirmatory trial underway at the time of approval should be the ‘default expectation’ and the agency should publicly explain when and why it grants exceptions to this rule, experts said at a National Academies meeting on accelerated approval.

Bubbles
To keep skepticism from bubbling up, FDA should explain why it didn't require a trial be underway at the time of approval. • Source: Shutterstock

The US Food and Drug Administration should publicly explain why a confirmatory trial need not be underway at the time a drug receives accelerated approval given the new statutory authority provided by Congress to mandate the timing of such studies, experts said at a National Academies of Sciences, Engineering and Medicine meeting.

Since the Food and Drug Omnibus Reform Act gives the agency clear authority to require that confirmatory studies be underway at the time of approval, the FDA should be transparent...

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