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Medical News & Perspectives
October 28, 2009

FDA Steps Up Efforts to Find, Remove Violators of Clinical Trial Regulations

JAMA. 2009;302(16):1739-1741. doi:10.1001/jama.2009.1518

Researchers who flout regulations for the conduct of clinical trials or who commit crimes related to clinical research may face swifter repercussions as the US Food and Drug Administration (FDA) intensifies its efforts to identify and remove violators from the drug and device development process.

Since the 1960s, the FDA has had the authority to disqualify or remove from FDA-regulated trials any clinical investigators who have “repeatedly or deliberately” ignored regulations designed to protect human research participants or who have repeatedly or deliberately submitted false information to the agency or the sponsor of their research. But this process often took years to complete.