Back to: Navigating Controlled Correspondences to Support Generic Drug Development
Presenter
Yan Wang, PhD
Deputy Director
Division of Therapeutic Performance I (DTP I)
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
Yan Wang from the FDA’s Office of Generic Drugs presents on mastering Controlled Correspondences (CCs), discussing their role, scope, common issues, and recommendations. CCs are written inquiries to the FDA for information on a specific element of generic drug development or certain post-approval requirements. They provide a specific inquiry channel allowing prospective applicants to obtain early feedback, proactively engage with the FDA, and seek input on critical development aspects. This process improves communication, clarifies expectations, and can reduce delays during development and ANDA assessment. CCs can address proposed analytical methods, BE study designs, alternative approaches to guidances, interpretation of regulations, and quality control strategies. Common issues include insufficient background, unclear or overly general questions, asking assessment-level questions prematurely, and mixing questions from different disciplines. Recommendations for preparing good quality CCs include providing sufficient background and data, proposing concise and specific technical or regulatory questions, seeking feedback on proposed strategies, and separating inquiries by discipline. The FDA also uses information from CCs to evaluate guidances and improve regulatory practices. Early engagement through high-quality CCs is encouraged.