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PER® Winter Lung Cancer Conference

Jorge J. Nieva, MD

If the FDA’s Oncologic Drugs Advisory Committee meeting held on February 10, 2022, was any indication, the days of applying foreign single country or region data to support regulatory approval are gone; instead, regulatory decisions are headed toward the need for regional consistency through multiregional clinical trials, which could help the United States overcome the persistent underrepresentation of racial and ethnic minorities in drug development.