Namita A. Goyal, M.D.
4 extracted findings
FDA source excerpt, selected passage
Failure to ensure that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations. [21 CFR § 312.60].
FDA published a close-out letter on Feb 19, 2025. The findings below are from the original warning letter.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Failure to ensure that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations. [21 CFR § 312.60].
Source passage selected by the model
02
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].
Source passage selected by the model
03
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].
Source passage selected by the model
04
Failure to prepare and maintain adequate and accurate case histories [21 CFR § 312.62(b)].
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.
21 CFR 312.6021 CFR 50.2021 CFR 312.6621 CFR 56.107(e)21 CFR 312.62(b)21 CFR 312.6221 CFR 31221 CFR 5021 CFR 56