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GUIDANCE DOCUMENT

Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry April 2024

Final
Docket Number:
FDA-2022-D-1173
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies conducted to support abbreviated new drug applications (ANDAs)2 to FDA Adverse Event Reporting System (FAERS). An ICSR captures information necessary to support the reporting of an adverse event related to an individual subject that is associated with the use of an FDA-regulated product.3 The electronic submission of the ICSRs from IND-exempt BA/BE studies is a voluntary option for submitting these required reports.


Submit Comments

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:

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-1173.

 
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