Namita A. Goyal, M.D.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to ensure that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations. [21 CFR § 312.60].

Passage 2

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].

Passage 3

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].

Passage 4

Failure to prepare and maintain adequate and accurate case histories [21 CFR § 312.62(b)].