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Dr. Amy Lightner, a sponsor-investigator conducting clinical studies with investigational biologic products, failed to ensure that investigations were conducted according to signed investigator statements, investigational plans, and applicable regulations under 21 CFR § 312.60. The FDA inspection (April 3-26, 2023) identified violations related to subject exclusion criteria and adverse event recording and reporting procedures that deviated from study protocols. These deficiencies were identified under the Bioresearch Monitoring Program, which evaluates whether human subject rights, safety, and welfare are adequately protected in clinical research.