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 adhere to this requirement. Specifically, Subject **(b)(6)** was randomized on **(b)(6)**, with 12 days of **(b)(4)**, and 0 days of **(b)(4)**. As such, this subject did not have the required e-Diary documentation of at least 2 or 4 days of **(b)(4)** and an average **(b)(4)** score of at least **(b)(4)**, respectively.
Passage 3You failed to adhere to these requirements. Specifically, protocol-required safety imaging procedures were not conducted for the following subjects:
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