FDA’s Oncology Center for Excellence Pilots Project Orbis: A framework for concurrent submission and review of oncology products among international partners

Abstract only e14125 Background: Cancer therapeutics often receive FDA approval months to years before regulatory submission to other countries. [i] Registrational trials in oncology are increasingly international, with many patients enrolled outside of the United States. Harmonizing access to new g...

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Bibliographic Details

Published in:	Journal of clinical oncology Vol. 38; no. 15_suppl; p. e14125
Main Authors:	Spillman, Dianne, Arora, Shaily, Venugopal, Rajesh, Scott, Bradley, Golding, Sarah, Richardson, Nicholas, Kasamon, Yvette L., Ethier, Jean-Francois, Gurd, Kate, Singh, Harpreet, DeClaro, R. Angelo, Beaver, Julia A., Kim, Tamy, Goldberg, Kirsten B., Kluetz, Paul Gustav, Theoret, Marc Robert, Pazdur, Richard
Format:	Journal Article
Language:	English
Published:	20-05-2020
Online Access:	Get full text
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