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Intarcia’s Fight To Win ITCA 650 Approval: Former Employees Object To FDA AdComm Presentations

 
• By Brenda Sandburg

In another case of criticism after an adcomm, three former Intarcia employees, including the key developer of the ITCA 650 device, contend agency made ‘erroneous statements’ about performance and manufacturing to the advisory committee that voted unanimously against the type 2 diabetes treatment.

Conflict
Former Intarcia employees back company in dispute with FDA over diabetes drug-device combo product. • Source: Shutterstock

The battle between Intarcia Therapeutics, Inc. and the US Food and Drug Administration’s Center for Drug Evaluation and Research over the safety and effectiveness of the ITCA 650 drug-device implant for type 2 diabetes has extended to former employees of the company who object to the agency’s presentations about the performance of the product at an advisory committee meeting.

The former employees, including the key developer of the device, sent a 10 October letter to FDA chief scientist...

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