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Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry August 2022


Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
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-0528

Docket Number:
Issued by:
Guidance Issuing Office
Center 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​​This draft guidance will assist prospective ANDA applicants in submitting expedited safety reports of serious adverse events (SAEs) from certain bioavailability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. 

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