The FDA has set up Project Facilitate to help oncology health professionals in requesting access to unapproved therapies for patients with cancer. The new initiative includes a call center, and represents a single point of contact where FDA oncology staff will help physicians treating patients with cancer through the process of submitting an Expanded Access request for an individual patient, including follow-up of patient outcomes.
Project Facilitate stands for an ongoing effort on the part of the FDA to help facilitate access to investigational medicinal products for patients with serious or life-threatening diseases, while simultaneously ensuring that their regulatory mandates (e.g. patient safety) are firmly in place.
The FDA recently issued guidances encouraging companies to broader their eligibility criteria to allow more patients with cancer to participate in clinical trials.
TrialSite News provides a link to the source press release below as well as relevant contact information below.
Project Facilitate’s phone number is 240-402-0004 and the email address is OncProjectFacilitate@fda.hhs.gov. Health care professionals may call during regular business hours, 9 a.m. to 5 p.m., Eastern Daylight Time, Monday through Friday. Patients and families with questions can call 301-796-3400 or email firstname.lastname@example.org.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.Source: FDA