FDA Project Facilitate
As a follow-on to the May 16 Workshop on Expanded Access, the FDA Oncology Center of Excellence officially launched Project Facilitate, a pilot program designed to assist physicians and patients through the Single Patient IND process. The pilot program is only for requests for oncology products for individual patients (Single Patient IND). A physician seeking guidance and assistance on requesting an investigational oncology drug may contact Project Facilitate by phone (240-402-0004) or email: OncProjectFacilitate@fda.hhs.gov. Healthcare professionals may call during regular business hours, 9 a.m. to 5 p.m., Eastern Eaylight Time, Monday through Friday. There is also a number of patients and families for questions, 301-796-3400 or email email@example.com. Early Access Care will continue to assist physicians who seek support through the Single Patient IND process as well. Early Access Care is always there to help physicians through this process and we view the new FDA Project Facilitate project as a wonderful step taken by the FDA to make access simpler.