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.

INTENDED AUDIENCE

• Members of the generic drug industry, including current and potential applicants who are interested in submitting an application for a generic drug
• Regulatory reviewers for generic drug development and assessments
• Consultants focused on bioequivalence, clinical research coordinators, and foreign regulators

OBJECTIVES

• Provide an overview of the final guideline and major changes from the draft guideline
• Delineate FDA’s planning on the implementation of M13A for generic drug applications
• Understand the purpose of the accompanying Q&A document
• Provide clarifications and explain ICH EWG ’s scientific thinking on selected topics

More Information 

1:00 PM – 3:00 PM ET