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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Wave’s Duchenne muscular dystrophy drug crashed, but Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.
Agency officials can now discuss the ideas that have been accepted, though not in great detail.
Outgoing Commissioner Scott Gottlieb will leave his successor a plate full of initiatives, should he choose to continue agency engagement of them.