Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].
Passage 2You 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 3You failed to obtain legally effective informed consent for Subject **(b)(6)**, who was enrolled in Protocol **(b)(4)**. Specifically, study-related screening procedures and the start of the placebo run-in period were performed before you obtained this subject’s written informed consent on the screening/main study informed consent form.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 312.60
- 21 CFR 312
- 21 CFR 50
- 21 CFR 50.20
- 21 CFR 50.23
- 21 CFR 50.24