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

August 2, 2022

Person typing on laptop with transparent icons floating around.

Guidance Document

August 2022

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 through the FDA Adverse Event Reporting System (FAERS) database. 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. The electronic submission of the ICSRs from IND-exempt BA/BE studies is a voluntary option for submission.

The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in FDA guidance means that something is suggested or recommended, but not required.

Download the Draft Guidance Document

Read the Federal Register

Interested in learning more? Contact us today to find out how we can help with your global regulatory needs

TAGS:

May 14, 2015

FDA Sets A Deadline For Electronic Submission Of Drug Applications

In a final guidance published in the Federal Register on May 5, FDA laid out the rules and specifications for providing regulatory submissions in electronic format. Perhaps more important than the...

FDA Works to Accelerate the Development of COVID-19 Treatments with New Guidance Documents

On Monday, May 11th, the FDA issued two guidance documents regarding the development of products indicated for the treatment and/or prevention of COVID-19. With these documents, the Agency intends to...

February 7, 2017

#3: Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route

In October 2015, the FDA published a guidance document which outlines its recommendations regarding “the nonclinical evaluation of previously approved drug substances when a new formulation or a new...