November 9-11, 2020 | Virtual Conference


Denise Conti, PhD

Senior Staff Fellow, Division of Therapeutic Performance (DTP), ORS, OGD, CDER

Dr. Denise Conti’s specialization is drug products in the nasal and oral inhalation drug delivery area as well as other types of drug-device combination products, e.g., injectable products. In her current role, Dr. Conti is responsible for the development of product-specific guidances for generic drug development, reviewing and responding to controlled correspondences, pre-ANDA meeting requests, citizen petitions, and internal consults. Dr. Conti is also the project officer on multiple regulatory science research initiatives related to nasal and oral inhalation drug products and device substitutability focusing on user interface considerations, under the GDUFA regulatory science research program. Prior to joining the FDA in 2013, Dr. Conti completed her B.Sc. in Chemical Engineering from Regional University of Blumenau (Brazil), her M.Sc. in Materials Science and Engineering from Santa Catarina State University (Brazil), and her Ph.D. in Chemical Engineering from the Wayne State University. Dr. Conti is the author and co-author on numerous research manuscripts in the oral inhalation drug delivery area.

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