Back to: Navigating Controlled Correspondences to Support Generic Drug Development
Presenter
Mark Donnelly, PhD
Senior Pharmacologist
Division of Quantitative Methods and Modeling (DQMM)
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
Mark Donnelly presents on the controlled correspondence (CC) process within generic drug development, with a specific focus on clinical pharmacology topics. The CC process serves as a mechanism for timely feedback from FDA on specific elements of generic drug development. The presentation covers different types of CC classifications and their associated timelines, detailing potential discussion topics such as clarifying published BE guidance, evaluating alternative BE approaches, study design, data analysis, and PBPK modeling applications. Case examples highlight alternative bioequivalence (BE) study designs proposed by applicants, including adaptive designs and various crossover designs for long-acting injectables, discussing their rationale, benefits, and potential concerns. Recommended practices for submitting CC inquiries are discussed, emphasizing the importance of providing all relevant data to avoid delays and suggesting consolidating questions. The presentation also points out that some requests may be better addressed through other mechanisms, such as product development meetings or the Model Integrated Evidence (MIE) pilot program. Overall, the CC process offers a way for applicants to solicit feedback from FDA on in vivo BE studies to help facilitate generic drug development.