Sponsor-investigator Receives FDA Warning Letter; BRANY Gets Determination Letter

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Sponsor-investigator Receives FDA Warning Letter; BRANY Gets Determination Letter

J.W. Schomisch

July 29, 2022 at 02:10 PM EST

The FDA sent a Warning Letter to a sponsor-investigator for failing to submit an Investigational New Drug application (IND) for clinical investigations and not obtaining informed consent and assent of children. In addition, the Department of Health and Human Services’ Office for Human Research Protections (OHRP) sent a July 13 Determination Letter to the Biomedical Research A... Read More

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Sponsor-investigator Receives FDA Warning Letter; BRANY Gets Determination Letter

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