Speakers

Dr. Sharon Ahluwalia is a Physician Assessor in the Division of Clinical Review in the Office of Safety and Clinical Evaluation within the Office of Generic Drugs at the Food and Drug Administration (FDA). In this role, she provides clinical assessment of generic drug products and ensures that allowable differences between a generic drug product and its reference listed drug do not alter the safety or efficacy profile. She began her FDA career in 2019 in the Office of Generic Drugs’ Office of Research and Standards where she provided clinical oversight for ongoing FDA and private partner-led research initiatives in addition to providing primary scientific and clinical assessment of queries made in the pre-submission stage of generic drug development. In 2021, she joined the Office of Bioequivalence that was later reorganized into the Office of Safety and Clinical Evaluation, where she continues to work today. Sharon Ahluwalia received her Doctor of Medicine from Northwestern University’s Feinberg School of Medication. She completed her residency in pediatrics at The Children’s Hospital of Wisconsin and her fellowship in Allergy and Immunology at The Johns Hopkins University. She continues to see patients at least monthly as an Allergist and Clinical Immunologist at Walter Reed National Military Medical Center, where she worked prior to joining the FDA.