FDA EIR - Charles Stephen Foster, M.D. - May 21, 2018

An FDA Clinical Investigator inspection was conducted at Charles Stephen Foster, M.D., in Waltham, MA, from May 9 to May 21, 2018. This premarket inspection, requested by the FDA's Center for Drug Evaluation and Research, focused on Dr. Foster's conduct of a Phase III clinical study (PSV-FAI-001) for a fluocinolone acetonide intravitreal insert, adhering to regulatory frameworks such as 21 CFR Part 312 for investigational new drugs. The inspection culminated in a Form FDA 483, detailing significant observations. The primary violation cited, under 21 CFR 312.60, was that the investigation was not conducted in accordance with the signed statement of the investigator and the investigational plan. Specifically, the unmasked treating investigator performed safety and efficacy assessments on numerous occasions after Day 1, which was a role designated for the masked investigator, introducing potential bias. Furthermore, a study subject was concurrently enrolled and treated in another ocular inflammation study, conflicting with the protocol's exclusion criteria.Three additional concerns were raised verbally: the site lacked access to an electronic Case Report Form (eCRF) for a transferred subject (violating 21 CFR 312.62(b) regarding case history maintenance), failed to retain monitoring editing notes and all Institutional Review Board (IRB) submissions, and inconsistently documented attending physician confirmations for student-performed eye examinations. Dr. Foster stated he would consider providing a written response to the FDA 483, implying the need for comprehensive corrective actions to address these deviations and ensure robust clinical trial integrity.