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 ONO PHARMA USA, INC. ("Ono")'s expanded access policy for drugs that are intended to treat serious diseases:   

Ono is not making any of its unapproved drugs available on an expanded access basis at this time. In the event that we decide to consider expanded access requests for our investigational drugs, we will evaluate and respond to each expanded access request on a case-by-case basis. In the event that we decide to make our products available on an expanded access basis, this policy will be updated with a hyperlink to the relevant expanded access record(s) on clinicaltrials.gov after such record(s) becomes active. Information about Ono's ongoing clinical trials can be found at clinicaltrials.gov. 

As authorized by the 21st Century Cures Act, Ono may revise this expanded access policy at any time. Additionally, the posting of this policy by Ono shall not serve as a guarantee of access to any specific investigational drug by any individual patient. If you have any questions about Ono's expanded access policy, please contact [email protected].