US FDA's Complex Trial Design Pilot May Change 'Ambitious' Timelines

Program allows eight months for sponsors to be accepted and conduct two meetings with FDA on an innovative design, but the agency said more time may be needed.

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The timeline for FDA's complex innovative trial designs (CID) pilot program may require adjustment amid worries the eight-month timeline is too long to fit plans for advancing a product to market.

Dionne Price, acting deputy director of the Center for Drug Evaluation and Research's Office of Biostatistics, said sponsors should consider the timeline when applying to the CID program

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