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FDORA Effect? For Accelerated Approval Class Of 2023, Most Confirmatory Trials At Least Underway

 
• By Sue Sutter

Of 11 NMEs and novel biologics, only one – a vaccine for a tropical disease – did not have confirmatory studies underway or completed at the time of accelerated approval. Statutory changes are forcing companies to prioritize confirmatory trials earlier than in the past.

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Sponsors are getting an earlier start on planning for confirmatory trials. • Source: Shutterstock

The Food and Drug Omnibus Reform Act (FDORA) gave the US FDA authority to require that confirmatory trials be underway at the time of accelerated approval. Although the legislation was signed into law just days before the start of 2023, the class of novel products that came to market under the expedited pathway last year reflects the philosophy behind that legislation.

Confirmatory studies were underway or completed at the time of approval for all but one novel accelerated approval product in...

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