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Device Component Of Intarcia’s Diabetes Treatment ITCA 650 Worries FDA

 
• By Brenda Sandburg

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.

Diabetes
FDA enumerates deficiences with diabetes drug-device combination treatment • Source: Shutterstock

If Intarcia Therapeutics, Inc. can convince FDA to convene an advisory committee to assess its new drug application for ITCA 650 (exenatide implant) for treatment of type 2 diabetes, the Center for Drug Evaluation and Research wants the panel to consider deficiencies with the device component among other issues.

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