THE DIRECTOR OF the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), Richard Pazdur, MD, joins ASCO Chief Executive Officer Clifford A. Hudis, MD, FACP, FASCO, in the latest ASCO in Action Podcast to discuss the FDA’s new program to make it easier for physicians to navigate the complicated Expanded Access process. Dr. Pazdur also discusses his approach for reviewing and approving cancer treatments and talks about the progress OCE has made since it launched more than 2 years ago.
Richard Pazdur, MD
Clifford A. Hudis, MD, FACP, FASCO
Project Facilitate—a new pilot program just for oncology—serves as a one-stop “concierge service” for physicians to bring all requests and questions related to Expanded Access. By centralizing these requests, the FDA will also be able to serve a wider group of patients, respond to requests more easily, and better understand the kinds of requests that pharmaceutical companies receive.
During the interview, Dr. Pazdur also discusses his approach to approving cancer drugs. “We have taken a very active approach to really rapid approvals of our drugs without sacrificing quality by having a smarter approach to how we review these drugs,” he says. “At the end of the day, I ask: will the American public be better off with this drug than without it?”
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