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Clinical Investigators - Disqualification Proceedings
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Clinical Investigators - Disqualification Proceedings


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1.Under regulations in effect until 1987, investigators who met the standard for disqualification (repeated or deliberate failure to comply with applicable requirements) could potentially avoid disqualification and continue to be eligible to receive investigational products if they could provide FDA with adequate assurances of future compliance with requirements applicable to the use of investigational drugs and biologics. The provisions for adequate assurances are no longer in the regulations.

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