Back to: FDA Generic Drugs Forum 2025
Presenter
Fang Yuan, PhD
Senior Pharmaceutical Scientist, Immediate Office (IO)
Office of Product Quality Assessment I (OPQAI)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Dr. Fang Yuan is a Senior Pharmaceutical Scientist in the Office of Product Quality Assessment I (OPQAI) within the Office of Pharmaceutical Quality (OPQ). As a senior drug product quality assessor for over 9 years at FDA, she currently conducts assessment of lifecycle applications, pharmaceutical equivalence, and policy inquiries such as citizen petitions. Her efforts in OPQAI also include managing ORISE fellowship program, coordinating overarching science communication and research activities, and serving as the point of contact for issues related to compendial standards and pharmacological toxicology consult requests for generic drug applications. Fang received her Ph.D. in Pharmaceutical Science from University of Nebraska Medical Center in 2014.
Abstract
At the 2025 Generic Drugs Forum, Fang Yuan from FDA’s Office of Product Quality Assessment I presents a retrospective analysis of first-cycle major complete response letters (CRLs) issued in FY2023 to identify common quality-related deficiencies in ANDA submissions. Her analysis of 284 CRLs reveals that over 70% of the 429 major deficiencies are quality-related, primarily in manufacturing (especially facility quality), drug product, and drug substance. She highlights frequent issues including inadequate extractables/leachables assessments, unqualified impurities, and insufficient drug substance sameness data, particularly for complex peptide products. Yuan emphasizes the importance of aligning with updated GDUFA guidance, improving submission quality, and strengthening communication with DMF holders to reduce deficiencies and increase first-cycle approval rates.