Back to: FDA Generic Drugs Forum 2025
Presenter
Xiaojian Jiang, PhD
Deputy Division Director
Division of Bioequivalence II (DBII)
Office of Bioequivalence (OB)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Dr. Xiaojian Jiang received her Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore. As a Divisional management and tertiary reviewer of complex BE issues, Dr. Jiang has successfully addressed numerous key scientific/regulatory issues of complex topical dosage forms, locally acting GI products, long acting injectables as well as nasal and inhalation products. During her tenure in the FDA, Dr. Jiang made significant contributions to the approval and regulation of generic locally acting GI drug products, including vancomycin, mesalamine and orlistat. She was the key speakers at various FDA, national and international venues. She has presented and published on a range of complex regulatory, scientific issues including Adaptive design approach for BE studies, deficiencies associated with IVRT, IVIVC issue and case studies, BE approaches for locally acting drug products, highly variable drug products, in vitro dissolution testing, and in vitro BE approaches for nasal spray products. She also led/participated in many working groups in development of a BE standard for methylphenidate modified-release formulations, NTI method development, NG tube study method and made leading effort to FDA general and individual guidance’s covering these areas.
Abstract
At the 2025 Generic Drugs Forum, Xiaojian Jiang presents case studies on the use of alternative reference standards in bioequivalence (BE) studies. He reviews the definitions of Reference Listed Drug (RLD) and reference standard (RS), FDA’s selection process when the RLD is unavailable, and criteria for using alternatives such as approved ANDAs or authorized generics. Jiang discusses six real-world cases submitted via controlled correspondence, highlighting when FDA accepts or rejects alternative BE study designs. He emphasizes that FDA decisions rely on product availability, scientific justification, and existing data, and encourages applicants to consult the agency beforehand.