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  1. 2022 OCE Annual Report

Other Professional Resources

Other Professional Objectives

Project Facilitate 

Project Facilitate is a comprehensive program assisting oncology healthcare and regulatory professionals in submitting Expanded Access requests to the FDA. In addition to providing support through email and phone, Project Facilitate staff also review all CDER oncology single-patient expanded access applications.

In 2022, Project Facilitate handled 397 phone calls and 637 expanded access applications; 96% (614/637) of applications were reviewed within 24 hours. This is consistent with the Project Facilitate mission to improve efficiency of review of oncology Expanded Access requests. The Project facilitate staff continued their educational outreach through presentations to clinics and hospital systems as well as an abstract submitted to the 2022 American Society of Clinical Oncology Annual Meeting.




Oncology Guidances 

The OCE led the development of five new draft guidances and 10 final guidances for oncology drug development in 2022. See all current oncology guidance documents at OCE Guidance Documents.

Draft Guidances:
Final Guidances:

OCE Publications and Approval Announcements

The OCE’s strong support for publications by FDA oncology/hematology staff continued in 2022, resulting in 87 articles in scientific journals. 

OCE’s Communications Team works with FDA clinical reviewers to issue approval announcements for most oncology/malignant hematology approvals; 40 of these were posted in 2022. 


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