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Home » FDA, OHRP Issue Informed Consent Waivers for IVDs in Emergencies
FDA, OHRP Issue Informed Consent Waivers for IVDs in Emergencies
June 9, 2006
The FDA and the HHS Office for Human Research Protections (OHRP) have responded to industry requests for harmonized regulations by issuing related guidance documents in the same week that allow informed consent waivers in clinical trials of in vitro diagnostic devices during a public health emergency.