At Genentech, our focus is on enrolling patients in clinical trials to obtain the data required for review and approval by regulatory authorities, including the U.S. Food and Drug Administration (FDA). In rare circumstances, we may provide patients with access to unapproved or investigational medicines outside the clinical trials process.
Once the FDA approves a medicine, qualified healthcare professionals may give it to patients by prescription. Before a medicine is approved, it is considered an "investigational" or "unapproved medicine." Patients can only access investigational or unapproved medicines through one of three ways: clinical trials, expanded access programs (EAPs) or compassionate use (CU).
To find a clinical trial, visit clinicaltrials.gov.
For more information on Genentech Trials, call the Trial Information Support Line at 1 (888) 662-6728.
Expanded access programs (EAPs) allow a limited group of patients to gain access to a specific investigational medicine before it is approved. These programs are designed to follow a specific clinical protocol. Companies who develop expanded access programs must do so in consultation with the Food and Drug Administration (FDA).
Compassionate Use (CU) is a way to provide an investigational medicine to an individual patient on humanitarian grounds when:
In the United States, The Food and Drug Administration (FDA) is responsible for approving the effectiveness and safety of medicines in the United States. In this capacity, the FDA oversees all aspects of how pharmaceutical and biotechnology companies develop, test, manufacture and commercialize medicines. Learn more about the FDA.
For Clinical Trials, call Genentech's Trial Information Support Line at 888-662-6728 (6 a.m. - 3 p.m. PST Monday to Friday). Please be prepared to provide relevant details, including but not limited to: