Short stories about how US FDA’s conference center changed since COVID-19 forced the end of in-person public events, what the agency did to officially close the books on Makena, and more.

Quick takes on Ultragenyx’s CEO lobbing the US FDA for rare disease policy changes, the agency naming a new deputy assistant commissioner for media affairs, the former CEO of AAM starting a consulting firm, and more.

Seeking to reverse CDER’s proposal to reject the NDA, Intarcia wants a say in formulating issues to be presented to the committee and questions inclusion of device experts as ad hoc members that will consider the fate of ITCA 650, a subdermal pump which delivers the GLP-1 agonist exenatide.

Approximately 41 months passed from the initial advisory committee meeting in October 2019 on Makena’s potential withdrawal to the 5 April 2023 final decision by FDA's commissioner and chief scientist - more than double the length of the same interval in the accelerated approval withdrawal proceeding involving the breast cancer claim for Genentech's Avastin.