Back to: FDA Generic Drugs Forum 2025
Presenters
Julia Yang, PhD
Pharmacologist, Division of Pharmacology/Toxicology Review (DPTR)
Office of Safety & Clinical Evaluation (OSCE)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Dr. Yang serves as a Pharmacologist in the Division of Pharmacology/Toxicology Review, within the Office of Safety and Clinical Evaluation, Office of Generic Drugs. In this role she evaluates toxicology justification to support the safety of excipient in the formulation and impurities in the product specification in generic drug products.
Prior to her service in OGD, Yang served as a research reviewer in Office of Vaccine Research and Review in CBER and reviewed the clinical and cellular immunogenicity studies in support of quality and efficacy in the vaccine products.
She received her M.S. in Biomedical Science from Texas A&M university and Ph.D. in Pharmacology from Temple University.
Qing Liu, PhD
Deputy Director, Division of Bioequivalence I (DBI)
Office of Bioequivalence (OB)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Dr. Qing Liu is the Deputy Division Director in the Division of Bioequivalence I, Office of Generic Drugs within the FDA’s Office of Generic Drugs. She has over 10 years of experience in the assessment of bioequivalence for abbreviated new drug applications, controlled correspondences, citizen petitions, product-specific guidance and protocols submitted to the Agency. In her current role, Dr. Liu works with a group of scientists on complex generic drug products, such as nasal/orally-inhaled drug products, long-acting injectables, topicals and ophthalmic suspensions.
Abstract
At the 2025 Generic Drugs Forum, Qing Liu and Julia Yang discuss the use of the Inactive Ingredient Database (IID) to justify excipient safety in Abbreviated New Drug Applications (ANDAs). Liu explains how the IID provides information on excipients in FDA-approved drug products, emphasizing its role in reducing review complexity when an excipient has been previously used. However, the database has limitations, such as a lack of data on safety for pediatric populations and chronic use. Yang addresses the non-clinical approach to excipient safety, highlighting the importance of context of use (dose, route, duration, patient population) in safety evaluation. She explains that discrepancies between the generic drug’s context and IID listings may require additional toxicological data. Through case studies, they demonstrate how the FDA assesses excipient safety and offers advice on how applicants can leverage the IID and provide necessary justifications to ensure safety, particularly when there are differences in context of use.