Intarcia, CDER Tussle Over Advisory Cmte. Process For Hearing On Denial Of Diabetes Combo Product

 
• By Brenda Sandburg

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.

Public meeting
FDA advisory committee to consider Intarcia's application for diabetes drug implant. • Source: Shutterstock

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