The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology.
Julie A SchneiderYutao GongKirsten B GoldbergPaul G KluetzMarc R TheoretLaleh Amiri-KordestaniJulia A BeaverLola A Fashoyin-AjeNicole J GormleyAdnan A JaigirdarSteven J LemeryPallavi S Mishra-KalyaniGregory H ReamanDonna R RiveraWendy S RubinsteinHarpreet SinghRajeshwari SridharaRichard PazdurPublished in: Clinical cancer research : an official journal of the American Association for Cancer Research (2021)
The FDA Oncology Center of Excellence (OCE) is a leader within the agency in scientific outreach activities and regulatory science research. On the basis of analysis of scientific workshops, internal meetings, and publications, the OCE identified nine scientific priority areas and one cross-cutting area of high interest for collaboration with external researchers. This article describes the process for identifying these scientific interest areas and highlights funded and unfunded opportunities for external researchers to work with FDA staff on critical regulatory science challenges.