2023/11/09
Title: Special Program with the FDA: Accelerated Approval in Oncology and Recent Legislation
Date: Thursday, November 9, 2023, 8:00am – 9:30am (doors open 7:45am)
Venue: Keio University Shiba-Kyoritsu Campus, Building No. 3, Room 1101
Shiba-Kyoritsu Campus: Keio University
Fee: Free of charge
Speakers:
Dr. Richard Pazdur, Director Oncology Center of Excellence (OCE), Office of the Commissioner (OC) and Acting Director, Office of Oncologic Diseases (OOD), Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. FDA
Dr. Angelo de Claro, Associate Director for Global Clinical Science OCE, OC, FDA and Director, Division of Hematology 1 (DHM1) OOD, OND, CDER, U.S. FDA
Event Description:
On November 9th, Keio University, with the support of the University of Southern California and the American Chamber of Commerce in Japan (ACCJ), is honored to host Dr. Richard Pazdur and a delegation of experts from the U.S. Food and Drug Administration (FDA) in a morning seminar focused on recent advances in U.S. regulatory policy.
FDA’s Accelerated Approval Program allows for earlier approval of drugs that treat serious conditions and fills an unmet medical need. This regulatory tool has been instrumental in bringing new treatment options for patients with cancer. At this session, FDA will highlight the 30 years of oncology experience with accelerated approvals and summarize the major updates to the program that were promulgated in the Food and Drug Omnibus Reform Act of 2022 (FDORA).
