Back to: M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Implementing the Final Guidance
🔔 Note: Stop playback at 1:10:51 to complete this lesson.
Presenter
Myong-Jin (MJ) Kim, PharmD
Director
Division of Therapeutic Performance II (DTPII)
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
Myong-Jin Kim, from FDA’s Office of Generic Drugs, details the agency’s substantial efforts to revise Product-Specific Guidances (PSGs) for immediate-release (IR) drug products, aligning them with the new M13A bioequivalence recommendations. A significant change involves removing recommendations for two bioequivalence (BE) studies (fasting and fed) for many products, often transitioning to a single study requirement. By October 2024, 814 revised PSGs were published, with 10 more planned by February 2025, which markedly reduces the burden on generic drug developers. These M13A-related PSG revisions are categorized as minor. Beyond M13A, other PSG updates include adding BCS-based bio-waiver options and revising administration recommendations for chewable tablets and ODTs to reflect more discriminating scenarios, like administration without water. The agency also updated study population recommendations, now specifying “healthy subjects” and incorporating considerations for the risk to females of reproductive potential. Further revisions address the use of reference-scaled BE approaches for highly variable drugs and update Risk Evaluation and Mitigation Strategies (REMS) language. These comprehensive revisions streamline global drug development, reduce the need for additional in vivo BE studies, and enhance access to generic drugs. Applicants can propose alternative approaches with appropriate scientific justification.