Could Postponement of Intercept’s Expected NASH Panel Impact Its PDUFA Date?

 
• By Joseph Haas

CDER’s postponing of meetings planned through the end of April likely means a later advisory committee date to review OCA in NASH. The US PDUFA date previously was pushed back to late June.

Building icon with inscription FDA and flag of The United States over abstract background. - Illustration
The status of imminent advisory committee reviews is in question with CDER's meeting cancellation notice

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