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Dr. Mobeen Mazhar failed to conduct clinical investigations in accordance with federal regulations governing investigational drugs and the protection of human subjects. During an FDA inspection of his clinical site between March 22 and April 28, 2022, investigators found that he did not adhere to applicable requirements under 21 CFR Parts 312 and 50, including a failure to ensure that clinical studies were conducted according to their investigational plans and that subjects met prescreening laboratory criteria and eligibility requirements before enrollment. The inspection was conducted as part of FDA's Bioresearch Monitoring Program, which evaluates research conduct to protect the rights, safety, and welfare of human research subjects.