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FDA Webinar: M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance

  • 1.  FDA Webinar: M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance

    Posted 10-03-2024 17:02

    FDA will host the webinar: M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance on November 21, 2024

    From 1:00 PM - 3:00 PM ET

    From the announcement:

    "This webinar will provide an update and overview on the final M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms guideline including major changes from the draft guideline and FDA's current bioequivalence (BE) guidance, delineate FDA's planning on the implementation of M13A, and address questions and provide clarifications based on questions/comments received during public consultation of the draft guideline."

    The major changes from the draft and current FDA BE guidance will make this webinar of interest to a large number of AAPS members who support BE studies.  More details and registration information at this link:

    https://www.fda.gov/drugs/news-events-human-drugs/m13a-bioequivalence-immediate-release-solid-oral-dosage-forms-implementing-final-guidance-11212024?utm_medium=email&utm_source=govdelivery

    #ICH #M13A #Bioequivalence #fda



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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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    </bioanalysisandbiomarkers.blogspot.com>