Back to: M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Implementing the Final Guidance
Presenter
Robert Lionberger, PhD
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
Robert Lionberger emphasizes the profound significance of M13A, highlighting it as a major shift towards global harmonization and efficiency for the FDA. He commends the extensive work of the presenters—Lei, Nilufer, and MJ—who, as technical representatives, dedicated years to building consensus globally and preparing internally within the FDA. This initiative involved changing over 800 Product-Specific Guidances (PSGs), a massive undertaking that required the FDA team to meticulously analyze data, including BCS class, solubility, and food effect for nearly 1,000 immediate-release products. This shift to a more efficient approach, reducing the number of required bioequivalence studies, avoids approximately 200 excess studies annually, leading to hundreds of millions of dollars in recurring savings for the generic industry. This streamlined process aims to foster a sustainable generic industry and improve access to generic drugs. Lionberger also acknowledges the crucial role of internal teams, including Qi, the IR team lead, and collaborators across the Office of Generic Drugs, ensuring that both scientific development and review processes adapt to these new, more efficient standards.