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# FDA Webinar on ICH Bioequivalence Guidance
- URL: https://www.fdaweb.com/fda-webinar-on-ich-bioequivalence-guidance/
- Published: 2023-03-14T12:00:00.000Z
- Updated: 2026-09-14T18:19:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153978

FDA has announced a 5/2 Webcast entitled “Navigating the First ICH Generic Drug Draft Guideline — M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms.” The Webinar will take an in-depth look into the draft guidance and explain the ICH’s current scientific thinking, and provide clarification on FDA’s implementation. of M13A, according to an [FDA notice](https://www.fda.gov/drugs/news-events-human-drugs/navigating-first-ich-generic-drug-draft-guideline-m13a-bioequivalence-immediate-release-solid-oral?ref=fdaweb.com).

The International Council for Harmonization [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m13a-bioequivalence-immediate-release-solid-oral-dosage-forms?ref=fdaweb.com) was issued 1/31 and is open for public comments until 4/3\. It provides recommendations for conducting bioequivalence studies during development and post-approval phases for orally administered immediate-release solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.