Giuseppe Randazzo is Senior Vice President of Sciences and Regulatory Affairs at the Association for Accessible Medicines. Prior to joining AAM, Giuseppe worked on Novartis’ regulatory affairs team, where he collaborated in multiple regulatory policy arenas including drug and policy development, UFA negotiations, and trade association relations. Before Novartis, Giuseppe spent nearly 15 years at the Food and Drug Administration (FDA), where he was most recently an Office Director leading a team of 220 employees under the FDA’s Center for Drug Evaluation and Research. During his time at FDA, Giuseppe also worked in the Office of New Drugs, the Office of Compliance, and helped stand up the Office of Product Quality in coordination with the Office of Generic Drugs.
Giuseppe holds a B.A. in Chemistry and Physical Science Education from The Pennsylvania State University and an M.S. in Regulatory Science from The Johns Hopkins University.
All Things Biosimilars: How Streamlined CES Rules Could Shift the Market
November 30th 2025In this special video episode of Not So Different, co-hosts Giuseppe Randazzo and Alex Keeton from the Association of Accessible Medicines tackle the FDA's recent draft guidance on comparative efficacy studies (CES) and interchangeability for biosimilars, addressing some of the confusion around the new announcement and remaining action items for the agency.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."