Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to prepare and maintain adequate documentation of IRB activities, including written procedures and IRB meeting minutes, raises concerns about the adequacy of the IRB’s review process. Furthermore, inadequate documentation of meeting minutes raises concerns about whether the IRB members maintained a quorum for the duration of the ACMH IRB meetings.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 56.115(a)(6)
- 21 CFR 56.108(a)
- 21 CFR 56.108(a)(1)
- 21 CFR 56.108(a)(2)
- 21 CFR 56.108(a)(4)
- 21 CFR 56.108(b)
- 21 CFR 56.115(a)(2)