Namita A. Goyal, M.D. — FDA Warning Letter Findings

Failure to ensure that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations. [21 CFR § 312.60]. A. Subjects were consented and enrolled in the study despite failing to meet required eligibility criteria outlined in the protocol. i. Subject (b)(6) participated in the study despite meeting exclusion criterion #13 for participation in another clinical trial within 30 days prior to their screening…

Failure to prepare and maintain adequate and accurate case histories [21 CFR § 312.62(b)]. A. You failed to record all adverse events (AEs) pertinent to the investigation for the following: i. Subject (b)(6) reported vomiting during a visit on (b)(6) and called to report significant pain after a gastrostomy procedure on (b)(6) . Neither AE was reported on the subject’s AE log. ii. Subject (b)(6) reported swelling on the ball of foot and cheek on January 14, 2019 that…

Failure to assure that an IRB that complies with the requirements set forth in 21 CFR part 56 is responsible for initial and continuing review and approval of the proposed clinical study and failure to obtain IRB approval prior to changes in research activity. [21 CFR § 312.66]. A. You failed to ensure that study personnel who were also IRB members did not participate in IRB reviews that may present conflicting interests, as required by 21 CFR § 56.107(e). (b)(6), (b)(4) was…

Failure to obtain legally effective informed consent prior to involving a human being as a subject in research … under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. [21 CFR § 50.20]. A. According to the IRB protocol application, written consent would only be obtained from study subjects. There were several instances…