Back to: M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Implementing the Final Guidance
🔔 Note: Stop playback at 25:31 to complete this lesson.
Presenter
Lei Zhang, PhD
Deputy Director
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
Lei Zhang, Deputy Director of the Office of Research and Standards at FDA’s Office of Generic Drugs, introduces the landmark M13A guidance, the first ICH guideline for bioequivalence, adopted in July 2024 and implemented by FDA in October 2024. This webinar provides an overview of M13A, clarifies its scientific thinking, and discusses FDA’s implementation for generic drug applications, including Product-Specific Guidance (PSG) revisions. Generic drugs, representing 90% of U.S. prescriptions, benefit from common global standards to improve access. M13A, part of a three-series guideline (M13A, B, C), harmonizes scientific and technical aspects for immediate-release (IR) solid oral dosage forms, focusing on study design and data analysis. A key change is the introduction of a risk-based approach to determine bioequivalence study conditions. High-risk products, which have a higher risk of bioinequivalence due to food effects, will require both fasting and fed bioequivalence studies, while non-high-risk products will generally only need one, typically fasting. This significant shift in FDA practice, differing from prior recommendations, is anticipated to result in annual savings of approximately $50 million in drug development costs. FDA has proactively revised over 800 PSGs to align with M13A, streamlining global drug development by often reducing the need for a second in vivo study.