Back to: Navigating Controlled Correspondences to Support Generic Drug Development
Presenter
Christopher Morgan, PhD
Pharmacologist
Division of Pharmacology/Toxicology Review (DPTR)
Office of Safety and Clinical Evaluation (OSCE)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
Chris Morgan from the Office of Safety and Clinical Evaluation (OSCE) presents on the role of controlled correspondences (CCs) in supporting generic drug safety assessment. OSCE, a multidisciplinary team involved throughout the generic drug lifecycle, responds to Level 2 CCs that require evaluation of clinical content within a 120-day timeline. These CCs provide guidance to help applicants align with the agency’s current thinking and improve submission quality, rather than constituting a complete safety assessment. Morgan reviews common CC topics, including those requiring input on the context of use (dose, route, duration, patient population). He also discusses feedback provided on proposed approaches to justify the safety of excipients and impurities, such as process and degradation impurities, extractables and leachables, and nitrosamines, detailing applicable thresholds and qualification methods. While CCs offer critical feedback, the final acceptability of safety justifications is determined during the ANDA technical assessment.