Project Facilitate Assisting Healthcare Providers with Expanded Access Requests for Investigational Oncology Products

https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate?utm_medium=email&utm_source=govdelivery Oncology Center of Excellence (OCE) Project Facilitate is a single point of contact call and information center created to help oncology healthcare providers or regulatory professionals submit an Expanded Access Request (also referred to as: Compassionate Use, Emergency IND, Single-Patient IND, or Pre-Approval) for an individual patient with cancer through FDA's Expanded Access Program. FDA’s Expanded Access Program allows patients with life-threatening diseases or conditions such as cancer try investigational medical products (drug, biologic, or medical device) when no satisfactory therapies are available and there is no opportunity for the patient to enroll in a clinical trial.