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FDA Will Revise Investigator Disqualification Regs In Response To GAO Report

This article was originally published in The Pink Sheet Daily

Executive Summary

The agency will revise its regulations to prevent clinical investigators who are disqualified from running trials for one product type to continue leading studies for other FDA-regulated categories.

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Sponsors of clinical trials can now include language in informed consent forms explaining that subjects are "donating" their blood, tissue or urine samples; previously, the term had been discouraged because of concern that it released sponsors from liability.

Informed Consent Guidance Allows Discussion Of Specimen "Donation"

Sponsors of clinical trials can now include language in informed consent forms explaining that subjects are "donating" their blood, tissue or urine samples; previously, the term had been discouraged because of concern that it released sponsors from liability.

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