FDA 483 - Nader Iskander, M.D. - August 06, 2021

Nader Iskander, M.D., a clinical investigator in San Antonio, TX, was cited for two significant observations during an FDA inspection. The firm failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan, including issues with subject eligibility and measurement scales. Additionally, the firm failed to obtain informed consent from human subjects using the most current IRB-approved version prior to drug administration and study-related tests.