Addressing Unmet Clinical Needs with Radiopharmaceutical Technologies
Blue Earth Diagnostics is committed to transforming the clinical management of patients with cancer in areas of unmet clinical need. We are focused on developing advanced imaging technologies and radiopharmaceuticals, which have potential utility in diagnostic imaging in cancer. These technologies can help physicians detect and locate cancer to make decisions about patient care.
We conduct scientific studies, called clinical trials, to find better ways to identify the location of cancer in the body and understand whether it can be effectively managed. Some of our clinical trials provide information on the benefits, side effects and possible uses for new technologies. Other trials explore new uses for existing imaging technologies. Results from clinical trials are submitted for review to Regulatory Authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These regulatory agencies have strict standards for the review of the safety and efficacy of new medicines or new uses of existing medicines. If these standards are achieved, a medicine may be approved and become available by prescription.
Expanded Access Policy - Information for US Healthcare Professionals and Patients
Expanded Access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational drug for treatment outside of a clinical trial when no comparable or satisfactory alternative therapy exists. Per FDA, Expanded Access may be appropriate when all the following apply:
- A patient has a serious disease or condition, or a patient’s life is immediately threatened by their disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrolment in a clinical trial is not possible.
- Potential patient benefits justify the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
Blue Earth Diagnostics is not currently making any of its investigational medicines available on an Expanded Access basis in the United States prior to regulatory approval.
Blue Earth Diagnostics may revise this Expanded Access Policy at any time and will publish the revised policy accordingly.
This Expanded Access Policy is being posted pursuant to Section 3032 of the 21st Century Cures Act and section 561 of the United States Food, Drug, and Cosmetics Act, as amended.
If you have questions, patients should speak with the treating physician. Physicians can contact Blue Earth Diagnostics via firstname.lastname@example.org.
PP-UK-0600 / March 2023