When Janet Woodcock retires early next year, Namandjé Bumpus will take over as No. 2 in command at the FDA. Since joining the agency in 2022 from Johns Hopkins, her profolio has included health disparities, cosmetics, and drug review disputes.

In another case of criticism after an adcomm, three former Intarcia employees, including the key developer of the ITCA 650 device, contend agency made ‘erroneous statements’ about performance and manufacturing to the advisory committee that voted unanimously against the type 2 diabetes treatment.

US FDA’s Oncologic Drugs Advisory Committee will convene in November for a ‘general discussion about delayed confirmatory trials’ and the ‘continued optimization of the accelerated approval process.’

However, FDA officials appear skeptical that imaging-based and circulating biomarkers are ready for prime time when it comes to supporting accelerated approval of drugs for noncirrhotic nonalcoholic steatohepatitis.