The Dermatology Innovation Webinar was held on Tuesday, September 19, 2023, with a panel of experts from the Food and Drug Administration discussing recent advances in topical drug assessment.
Webinar registration is complimentary because of the generosity of AID's sponsors.
Dr. Tannaz Ramezanli is a senior pharmacologist within the Office of Research and Standard (ORS) at Office of Generic Drugs (OGD) at the U.S. FDA. She specializes in topical and transdermal products. She is responsible for the development of product-specific bioequivalence guidances, reviewing and responding to controlled correspondences, citizen petitions, and Pre-ANDA meeting packages. She also leads multiple regulatory science research initiatives related to development of bioequivalence standards for complex topical drug products through FDA-funded collaborations with research institutions around the world. She received her Ph.D. in Pharmaceutical Sciences from Rutgers University and her Pharm.D. from Tehran University of Medical Sciences.
Dr. Priyanka Ghosh is a lead pharmacologist within the Division of Therapeutic Performance, ORS, OGD. Her areas of expertise include products in the topical and transdermal drug delivery area. In her current role, Dr. Ghosh leads regulatory science research initiatives related to topical, transdermal and transmucosal drug products, under the GDUFA regulatory science program. Dr. Ghosh also leads the development of general and product-specific guidances, review strategies for industry meeting requests and citizen petitions and is the co-chair of the Bioequivalence Standards for Topicals Committee within OGD. Prior to joining FDA, Dr. Ghosh completed her Bachelor’s degree in Biotechnology from West Bengal University of Technology (India) and a Ph.D. in Pharmaceutics and Drug Design from the University of Kentucky.
Dr. Luke is a Supervisory Physician and Director of the Division of Therapeutic Performance (DTP1) in the Office of Research and Standards, Office of Generic Drugs at FDA. DTP1 is responsible for facilitating pre-application development of generic drugs by conducting and promoting regulatory science research to establish standards to ensure therapeutic equivalence of new generic drug products. Markham has an MD and a PhD in Pharmacology from Johns Hopkins University and is a dermatologist by training. Markham has been at FDA since 1998 serving various roles