The US Food and Drug Administration’s drugs center plans to leverage its new Center for Clinical Trial Innovation (C3TI) not only as a hub for experience with innovative trial approaches, but also to alleviate fears that the agency’s inspectors will not understand the strategies and that global regulators will not accept them.
C3TI's Mission: Leverage FDA Trial Innovation Expertise, Educate Inspectors
The Center for Clinical Trial Innovation was created to be CDER’s hub for expertise and information on innovative clinical trial approaches. C3TI lead Kevin Bugin talks to the Pink Sheet about the program's genesis and what it hopes to accomplish.
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