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FDA releases Final Guidance: Providing Regulatory Submissions in Electronic Format: IND Safety Reports

  • 1.  FDA releases Final Guidance: Providing Regulatory Submissions in Electronic Format: IND Safety Reports

    Posted 04-01-2024 09:48

    This guidance specifies the requirements electronically for submitting "serious and unexpected suspected adverse reactions to FDA in an IND safety report within 7 or 15 days depending on the severity of the event (21 CFR 312.32)".  The reporting format is consistent with that of those of the"International Council for Harmonisation (ICH) guidelines and reporting requirements to other regulatory agencies".  The guidance does note that some studies are exempt "BA and BE studies that meet the conditions for exemption under 21 CFR 320.31 are not conducted under an IND and are not subject to the IND safety reporting requirements".  For more details, please access and read the full guidance:

    #fda #SafetyReporting #AdverseEvent

    https://www.fda.gov/media/132079/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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