Back to: FDA Generic Drugs Forum 2025
Presenter
Paramjeet Kaur, PhD
Team Leader
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. Paramjeet Kaur is a Lead Pharmacokineticist in the Division of Bioequivalence II. In this role, she leads a team of scientists assessing the bioequivalence of the various dosage forms of generic drugs. She is also involved in addressing controlled correspondences and pre-ANDA meeting packages, as well as the development and revision of both product specific and general guidances. Dr. Kaur received her Bachelor of Pharmacy from the Banaras Hindu University, India, and Doctorate in Industrial Pharmacy from St. John’s University, NY.
Abstract
At the 2025 Generic Drugs Forum, Paramjeet Kaur presents on bioequivalence (BE) approaches for nitrosamine-impacted generic drug applications, focusing on FDA’s alternative BE pathway outlined in the 2024 nitrosamine guidance. She explains that since 2018, several drug products have been affected by nitrosamine impurities, prompting formulation changes such as use of antioxidants or pH modifiers. The guidance allows comparative dissolution data in lieu of in vivo studies under specific conditions, but excludes narrow therapeutic index drugs and certain dosage forms. Through four case studies, Kaur illustrates how FDA evaluates formulation changes and determines data requirements based on drug properties, change level, and dosage form design. She emphasizes the importance of a risk-based approach in applying the alternative BE pathway and concludes by acknowledging the collaborative efforts within FDA.