Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” - 05/02/2023

[FDA]

Webinar will take an in-depth look at the draft guidance, explain the ICH Expert Working Group’s current scientific thinking on selected topics, and provide clarification on FDA’s planning on the implementation of M13A for generic drug applications.


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