FDA’s CDER Looking Towards Quicker Accelerated Approval Withdrawal Approach

May 24, 2023

The US Food and Drug Omnibus Reform Act (FDORA) empowered the Center for Drug Evaluation and Research (CDER) with the ability to expedite the withdrawal of drugs that were granted accelerated approval if confirmatory trials are not successful. The new process, which has yet to be rolled out, will be covered in a new guidance that will be up for public comment.

According to Zachary Brennan, “The sponsor can meet with the commissioner and appeal and has a right to an advisory committee meeting under FDORA, she said, but noted that the update means the FDA won’t need to do more than one adcomm, as the agency did with Makena, ‘so this should really streamline this process,’ Corrigan-Curay said.”

To read more, click here.

(Source: Endpoints News, May 24th, 2023)

Share This Story!