Arena Pharmaceuticals Expanded Access Policy
Arena Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel, small molecule drugs. Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or 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 Arena’s expanded access policy for drugs that are intended to treat serious diseases:
(1) Contact Information. A treating physician may submit questions or requests regarding expanded access to the following: firstname.lastname@example.org.
(2) Request Procedures. All physicians submitting questions or requests are required to comply with all applicable laws and regulations, and agree that they have all rights and authorizations necessary to provide any information that is submitted by them through the website and to allow us to use, review, and evaluate the submitted information in connection with the expanded access request.
(3) General Criteria. Arena will evaluate and respond to each expanded access request that it receives on a case-by-case basis.
(4) Anticipated Timing. Arena anticipates that it will acknowledge receipt of any expanded access questions or requests within seven (7) business days of receipt.
As authorized by the 21st Century Cures Act, Arena may revise this expanded access policy at any time. Additionally, the posting of this policy by Arena shall not serve as a guarantee of access to any specific investigational drug by any individual patient.