Reform efforts in CDER include ensuring expertise is specific to the issues being discussed, which may mean more temporary voting members on advisory committees.

Accelerated approval for primary biliary cholangitis in 2016 came with three postmarketing requirements, but studies were terminated early; firm working toward sNDA submission in 2023 for regular approval, but US FDA says reports already are overdue and it expects to take PBC indication back to an adcomm.

In this week's podcast edition of Five Must-Know Things: novel BMS drug shows promise in IPF; Novo’s oral semaglutide compares well with injectable in weight loss; Teva looks to innovative brands to return to growth; US setback for Intercept’s NASH drug; and India’s improving environment for clinical trials.

When the first non-alcoholic steatohepatitis drugs reach market, the health cost watchdog says payers will be justified in setting step-therapy including weight-management efforts, while early prescribing should be by specialists.