Open AccessOncology Expanded Access and FDA 's Project Facilitate
Author(s) -
Scepura Barbara,
Chan Mitchell,
Kim Tamy,
Boehmer Jessica,
Goldberg Kirsten B.,
Pazdur Richard
Publication year - 2021
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1002/onco.13910
Subject(s) - medicine , expanded access , investigational drugs , food and drug administration , center of excellence , compassionate use , drug development , drug approval , excellence , oncology , clinical trial , drug , medical emergency , pharmacology , political science , law
The Oncology Center of Excellence at the U.S. Food and Drug Administration launched Project Facilitate on May 31, 2019, to assist oncology health care providers with Expanded Access requests for investigational drugs. Expanded Access, sometimes called “compassionate use,” is a regulatory pathway for physicians caring for patients who have a life‐threatening condition or a serious disease to gain access to an investigational drug for treatment when no comparable or satisfactory alternative treatment options are available. Herein we describe the Project Facilitate program and the process for requesting Expanded Access to an investigational drug.