Device Component Of Intarcia’s Diabetes Treatment ITCA 650 Worries FDA
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.
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A US FDA advisory panel feels there could be a place for Intarcia’s exenatide drug-device combo – if the company is willing to put in the work.
US FDA advisory panel feels there could be a place for Intarcia’s exenatide drug-device combo – if the company is willing to put in the work.
Intarcia Gets Its Hearing: FDA Panel To Weigh Nonapproval Of Diabetes Drug/Device Combo In September
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.