H3 Biomedicine also supports expanded access to investigational products where there is preliminary scientific evidence to support the use of a product for an indication when it is logistically feasible and when permitted by applicable law.
Expanded access refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. This is different from a clinical trial, where more comprehensive safety and efficacy data are collected. The intent of an expanded access program is to provide patients with access to investigational medication for serious diseases or conditions where there is no comparable or satisfactory alternative therapy available. We understand the need for expanded access programs, and we recognize the importance of having an appropriate policy.
H3 Biomedicine will consider a number of factors consistent with the US Food and Drug Administration (FDA) and other regulatory agencies’ guidelines when reviewing requests for expanded access.
All individual requests will be evaluated in a fair, unbiased manner, and we anticipate acknowledging receipt of requests sent to clinicaltrials@h3biomedicine.com within five (5) business days.
At this time, H3 Biomedicine believes that participation in one of our clinical trials is the most appropriate way to access our investigational therapies. If you have additional questions, please speak with your physician or contact clinicaltrials@h3biomedicine.com.
Consistent with the 21st Century Cures Act, H3 Biomedicine is publicly disclosing their policy on making investigational drugs available for expanded access and may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.