The FDA released a second guidance today related to safety reporting - however, this one is much narrower in the applicable clinical studies "Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies" and appears to address the exemption in the previously released guidance on electronic format of safety reporting for clinical studies. The introduction lays out the rationale for the guidance:
"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) 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. The electronic submission of the ICSRs
from IND-exempt BA/BE studies is a voluntary option for submitting these required reports."
#fda #ANDA #BE #BA #SafetyReporting
https://www.fda.gov/media/177371/download
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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