The skirmish between Intarcia Therapeutics, Inc. and the US Food and Drug Administration’s Center for Drug Evaluation and Research over the company’s NDA for its exenatide implant ITCA 650 has extended into the planning of an advisory committee meeting. The panel is the firm’s chance to challenge CDER’s plan to refuse the application.
Intarcia, CDER Tussle Over Advisory Cmte. Process For Hearing On Denial Of Diabetes Combo Product
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.
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