Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to Report Drugs
Passage 2Failure to Report Adverse Events
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.115
- 21 CFR 310.305
- 21 CFR 310.305(c)(1)