Division Director
US Food and Drug Administration
Dr. Bhagwant Rege is the Division Director for the Division of Modified Release Products in CDER/OPQ/OLDP at the FDA. Prior to joining FDA in 2010, he worked at Merck & Co. for about 9 years in oral biopharmaceutics and formulation development groups. At Merck, he was responsible for evaluating impact of material properties on oral absorption and development of market formulations of NCEs and product extensions. His division at FDA is responsible for collaborative evaluation and assessment of Abbreviated New Drug Applications (ANDAs) for modified release drug products and making risk-informed recommendations on their approvability. Bhagwant has served as a team leader and review chemist in the Office of Generic Drugs where he was part of the team that developed the Quds examples for the generic industry. He is a member of the FDA Emerging Technology Team (ETT), ICH Q12 Expert Working Group (EWG), and FDA liaison on the USP expert committee on dosage forms general chapter (2015-2020).
Bhagwant received his Bachelors and Masters in pharmacy from the University of Mumbai, India and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore.