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Intarcia Gets Its Hearing: FDA Panel To Weigh Nonapproval Of Diabetes Drug/Device Combo In September

 
• By Sue Sutter

Since the Center for Drug Evaluation and Research is conducting the single-day hearing on the type 2 diabetes treatment ITCA 650 under its usual process for advisory committee meetings, it denied Intarcia’s requests for input on adding ad hoc members and extended presentation time.

Boxing gloves
FDA and Intarcia will duke it out at an Endocrinologic and Metabolic Drugs Advisory Committee meeting on 21 September. • Source: Shutterstock

The US FDA’s Center for Drug Evaluation and Research has scheduled a September advisory committee hearing on its intent to deny approval of Intarcia Therapeutics, Inc.’s exenatide implant ITCA 650.

However, the drugs center is making clear that it does not intend to stray from its “usual practice” of conducting advisory committee meetings, rejecting the sponsor’s request for increased presentation

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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