Back to: FDA Generic Drugs Forum 2025
Presenter
Ravikanth Kona, PhD
Pharmaceutical Scientist
Division of Product Quality Assessment I (DPQA I) Office of Product Quality Assessment I (OPQA I) Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Dr. Ravikanth Kona is a Pharmaceutical Scientist in Division of Product Quality Assessment I, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research. Dr. Kona is an experienced Drug Product Reviewer with over 8 years of regulatory experience within the U.S Food and Drug Administration in reviewing, evaluating, assessing scientific and regulatory information of complex generic drug products in CMC submissions.
Prior to joining the agency, Dr. Kona worked as Pharmaceutical Technology Specialist, Principal in Pharmaceutical industry overseeing commercial process development and process optimization of oral dosage forms. Dr. Kona holds a Ph.D. in Pharmaceutical Sciences from University of Maryland, Baltimore, an M.S. in Chemistry from Missouri State University, and B.S. in Pharmacy from Osmania University.
Abstract
At the 2025 Generic Drugs Forum, Ravikanth Kona, a drug product assessor in OPQ, presents an overview of quality considerations for drug products labeled for alternate dosing administration. He defines alternate dosing as the use of non-standard routes—such as mixing with soft food or liquids, use with enteral feeding tubes, or as admixtures—and outlines key FDA guidance and data submission requirements. Kona emphasizes the importance of evaluating compatibility, stability, and palatability, along with proper in vitro testing to ensure safety and efficacy. Through detailed case studies, he illustrates common deficiencies and regulatory expectations, aiming to help sponsors provide robust data and reduce review cycles.