Nurix Therapeutics, Inc., Expanded Access Policy to Investigational Drugs
Consistent with Nurix’s mission to bring innovative, safe and effective medicines to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective therapies. We believe this approach will serve patients who could be helped by the therapies we are developing.
Expanded access programs, also known as “pre-approval access” or “compassionate use”, are potential pathways for patients to receive investigational drugs that are not yet approved by the FDA or other regulatory authorities but may be beneficial for patients with serious or life-threatening conditions. Under these programs, patients who are unable to participate in a clinical trial may potentially receive the investigational drug outside of a clinical trial. Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug. The following is Nurix’s policy for responding to requests for expanded access to investigational drugs that are intended to treat serious diseases.
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