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JAMA. 1998;279:9.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

As part of its regulation of scientific studies designed to provide evidence of safety and effectiveness of medical products, the agency on occasion may disqualify a physician or other health professional from receiving investigational drugs, biologics, or devices. This occurs if the FDA has determined that the investigator repeatedly or deliberately failed to comply with regulatory requirements for studies or submitted false information to the study's sponsor.

Disqualifying investigators when necessary helps ensure the safety of subjects and the integrity of the testing process. Before disqualification or other sanctions occur, the investigator is given an opportunity for a hearing and other due process measures. Investigators may be required to agree to certain restrictions on their conduct in future studies or to make certain assurances regarding the performance of future studies.

To facilitate public access, the FDA recently added its "Disqualified/Restricted/Assurance List for Clinical Investigators" to its Internet Web site; the . . . [Full Text of this Article]

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