Mark J. Savant, 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

You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].

Passage 2

You failed to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR 50.20].

Passage 3

You failed to obtain legally effective informed consent for two subjects before their enrollment in Protocol **(b)(4)**. Specifically, Subjects **(b)(6)** and **(b)(6)** signed the “Phase III Main Informed Consent Form” on January 17, 2022; however, neither subject signed the “Informed Consent Form Addendum for Study Drugs.”