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Home » FDA, OHRP Issue Coordinated Documents on Informed Consent Waivers
FDA, OHRP Issue Coordinated Documents on Informed Consent Waivers
June 14, 2006
The FDA and OHRP appear to be responding to industry calls to coordinate their activities by issuing separate but related documents in the same week allowing exemptions from informed consent rules in clinical trials of in vitro diagnostic (IVD) devices during a public health emergency.