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

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.

Neurotrack Technologies revises website “to ensure that its communications better align with its evidence-backed offerings” following a National Advertising Division review of an advertising challenge by Posit Science.

If FDA chief scientist grants Intarcia’s request for advisory committee meeting, CDER wants to provide input on issues to be considered. Director Cavazzoni says the novel drug-device combination product does not notify the user of a critical failure or infusion status.