https://www.bioworld.com/articles/435871-back-to-normal-fda-adcom...

https://www.bioworld.com/articles/435871-back-to-normal-fda-adcom-meets-but-questions-loom-over-others

While the FDA holds adcoms for opioid applications and the first biosimilar to target a biologic, it typically convenes an adcom for other drugs and devices only when it needs the scientific and clinical expertise of the committee members in weighing the risk-safety profile of a product or to answer unresolved questions about the interpretation of data, trial conduct, safety signals, etc. While sponsors may anticipate an adcom, they don’t know if one will be required until informed of it by the FDA.

Going forward, Yang said two adcom meetings are expected ahead of September 2020 PDUFA dates – for Mallinckrodt plc’s terlipressin, being evaluated as a treatment of hepatorenal syndrome type 1, and Mesoblast Ltd.’s Ryoncil (remestemcel-L), an allogeneic cell therapy for children with steroid-refractory acute graft-vs.-host disease.