Rexahn Pharmaceuticals Expanded Access Policy
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 Rexahn’s expanded access policy for drugs that are intended to treat serious diseases:
- Contact Information. Please submit any questions or requests regarding expanded access by calling us at +1-240-268-5300.
- Request Procedures. Please submit sufficient supporting detail to enable us to evaluate the expanded access request. Please also include your contact information so that we may follow-up with you directly.
- General Criteria. Rexahn is not making 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.
- Anticipated Timing. We anticipate that it will acknowledge receipt of any expanded access questions or requests within 15 business days of receipt.
- Clinicaltrials.gov Hyperlink. Rexahn is not currently making its unapproved drugs available for expanded access use. 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.
As authorized by the 21st Century Cures Act, Rexahn may revise this expanded access policy at any time. Additionally, the posting of this policy by Rexahn shall not serve as a guarantee of access to any specific investigational drug by any individual patient.