Back to: Navigating Controlled Correspondences to Support Generic Drug Development
Presenter
Pamela Dorsey, PhD
Senior Pharmacologist
Division of Bioequivalence III (DB III)
Office of Bioequivalence (OB)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
Dr. Pamela Dorsey from the Office of Bioequivalence presents on Bioequivalence Considerations for Controlled Correspondences. She outlines the various types of controlled correspondences (CCs) assessed by her office, including those related to inactive ingredient evaluations, reference standard use, and changes to approved ANDAs. She differentiates between Level 1 (standard) and Level 2 (complex) CCs, explaining the 60-day and 120-day review timelines, respectively, and noting that Level 2 includes complex topics like alternate bioequivalence (BE) approaches. Dr. Dorsey provides detailed examples for commonly assessed categories, such as the evaluation of proposed maximum daily exposures (MDEs) for inactive ingredients, emphasizing the “Three and Three recommendation” for submissions. She also covers the use of reference standards not listed in the Orange Book, explaining how the Office of Bioequivalence may suggest alternate BE approaches when the reference standard is unavailable. Finally, she discusses prior approval supplements for changes to approved ANDAs, highlighting that in vivo BE studies should utilize the current reference standard rather than comparing pre- and post-change products.