Back to: FDA Generic Drugs Forum 2025
Presenter
Churg (Stella) Chan, PharmD, BCPS
Pharmacist, Division of Labeling Review (DLR)
Office of Regulatory Operations (ORO)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Dr. Churg “Stella” Chan serves as a primary assessor for the Division of Labeling Review (DLR) within the Office of Regulatory Operations (ORO), Office of Generic Drugs (OGD) since 2021. As a primary assessor, Stella reviews labeling for generic drug products, such as Prescribing Information, container and outer packaging, Medication Guides, and other patient labeling to ensure its accuracy and safety when compared with the reference listed drug (RLD). She also works with other Divisions and Offices within the agency, if necessary, to ensure that the labeling is accurate and is in accordance with the RLD, guidances, and regulations.
Previously, she served as a primary biopharmaceutics assessor within the Office of Pharmaceutical Quality (OPQ). Prior to joining the FDA in 2019, Stella was an internal medicine pharmacist at MedStar Union Memorial Hospital in Baltimore, MD. She received her Doctor of Pharmacy from the University of Maryland, Baltimore in 2015.
Abstract
At the 2025 Generic Drugs Forum, Stella Chan from the Division of Labeling Review presents best practices for generic drug labeling. She outlines how Abbreviated New Drug Application (ANDA) holders should update labeling in alignment with the reference listed drug (RLD), emphasizing timely updates and compliance with the Physician Labeling Rule (PLR). Chan reviews requirements for addressing patents and exclusivities, stressing the need for accurate certifications and proper carve-outs. She highlights the importance of submitting labeling changes under the correct reporting category—such as CBE supplements for specific updates—and discusses recent guidance on distributing electronic medication guides via URLs or QR codes. Throughout the session, Chan engages the audience with challenge questions to reinforce regulatory knowledge, concluding with a call for adherence to labeling standards to support timely approval of safe, effective generics.