FDA Proposes Non-U.S. Clinical Trials Follow Good Clinical Practices
This article was originally published in The Gray Sheet
The Feb. 25 proposed rule amends regulations on acceptance of data from medical device clinical trials done outside the U.S. to support any submission to FDA to comply with good clinical practice standards.
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FDA has been accepting data from patients outside of the U.S. to support device approvals for years, but the sponsor should check with the agency in advance to ensure the foreign data meets the needs of the U.S. regulatory system, according to a new draft guidance. The guidance details the factors that could stand in the way of FDA accepting foreign data and provides examples of what could be done about it.
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