Back to: FDA Generic Drugs Forum 2025
Presenter
Ying Fan, PhD
Team Lead
Division of Clinical Review (DCR)
Office of Safety and Clinical Evaluation (OSCE)Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Dr. Ying Fan is the Lead Pharmacologist in Division of Clinical Review, Office of Safety and Clinical Evaluation, Office of Generic Drugs. She received her Ph.D. in major of Pharmaceutical Sciences and minor of Statistics from Oregon State University. During her more than 16 years tenure in the FDA, she made significant contributions to the approval and regulation of local acting drug products and complex generic drug products. She is a subject matter expert in comparative clinical endpoint study review and a valuable mentor in training new reviewers. She has been an active member on various committees and working groups within FDA. She initiates, leads or participates in multiple research projects, general guidances and product specific guidances development or revision.
Abstract
At the 2025 Generic Drugs Forum, Ying Fan from the FDA’s Office of Generic Drugs discusses common clinical deficiencies in abbreviated new drug applications (ANDAs) that include comparative clinical endpoint bioequivalence (CCEP BE) and irritation, sensitization, and adhesion (I/S/A) studies. She outlines the goals and design of these studies, emphasizing their role in demonstrating bioequivalence and safety for locally acting drugs where pharmacokinetic studies are not feasible. Fan details common deficiencies, such as missing documentation, inconsistent information, and inadequate justification, and stresses the importance of adhering to FDA guidances—particularly product-specific guidance—to minimize review delays.