- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
This draft guidance will assist prospective ANDA applicants in submitting expedited safety reports of serious adverse events (SAEs) from certain bioavailability (BA)/bioequivalence (BE) studies in electronic format. Under 21 CFR 320.31(d)(3), persons conducting human BA and BE studies in the United States that are exempt from the IND requirements under part 312 must report any serious adverse events from the study to FDA and to all participating investigators. SAEs had been submitted to OGD via email, telephone, or facsimile transmission with FDA forms as attachments. Enhancements to the FDA Adverse Event Reporting System (FAERS) will allow electronic submission of premarket safety reports in compliance with ICH guidance and data specifications for studies conducted under IND and BA/BE studies that are IND-exempt. The guidance provides specifications, recommendations, and general considerations to inform electronic submission of expedited safety reports.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2022-D-1173.