FDA Launches ‘Project Facilitate’ to Improve Access to Unapproved Cancer Therapies
The FDA Oncology Center of Excellence announced a new pilot program called Project Facilitate. Its purpose is to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer. A newly minted and dedicated call center will be the single point of contact for the pathway known as Expanded Access. This pathway is dedicated to patients with an immediately life-threatening or serious disease or condition, allowing them to gain access to an investigational medical product (drug, biologic or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory alternative therapy options available. The FDA announcement included the following
Expanded Access is a pathway for a patient with an immediately life-threatening or serious disease or condition to gain access to an investigational medical product (drug, biologic or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory alternative therapy options available.
A resource designed to educate patients and health care professionals about the FDA Expanded Access process. The Navigator offers information provided by companies about their Expanded Access policies and now includes Expanded Access programs listed in ClinicalTrials.gov
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