Lutroo Imaging, LLC
Expanded Access Policy

Under the 21^st 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 on an expanded access basis.  This policy outlines Lutroo Imaging’s approach to providing investigational PET radiotracers to patients outside of clinical trials under the FDA’s Expanded Access provisions.

1. Contact Information.  Lutroo is not making its unapproved drugs available on an expanded access basis at this time.  If you have any questions about Lutroo’s expanded access policy, please contact info@lutrooimaging.com.  
2. Request Procedures.  Although Lutroo is not planning to make its unapproved drugs available on an expanded access basis at this time, if you would like to submit an expanded access request, please feel free to submit sufficient supporting detail to enable Lutroo to evaluate your request.  Please also include your contact information so that Lutroo may follow-up with you directly.
3. General Criteria.  Lutroo is not making its unapproved drugs available on an expanded access basis at this time.  In the event that Lutroo decides to consider expanded access requests for Lutroo’s investigational drugs in the future, Lutroo will evaluate and respond to each expanded access request on a case-by-case basis.  
4. Anticipated Timing.  Lutroo anticipates acknowledging receipt of any expanded access questions or requests within five business days of receipt.  As noted above, Lutroo is not making its unapproved drugs available on an expanded access basis at this time.
5. Clinicaltrials.gov Hyperlink.  Lutroo is not currently making its unapproved drugs available for expanded access use.  In the event that Lutroo decides to make its 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 records become active.  

As authorized by the 21^st Century Cures Act, Lutroo may revise this expanded access policy at any time.  Additionally, the posting of this policy by Lutroo shall not serve as a guarantee of access to any specific investigational drug by any individual patient.