Emerald Health Pharmaceuticals’ Expanded Access Policy
Emerald Health Pharmaceuticals (EHP) is a biotechnology company focused on developing novel product candidates for the treatment of diseases with unmet medical needs, primarily inflammatory, autoimmune, neurodegenerative and fibrotic diseases.
Patients are at the center of our commitment. EHP is dedicated to fully answer important questions about the potential risks and clinical benefits of our investigational drugs, in order to obtain regulatory approval to eventually allow those drug products to become widely available to patients. However, until such regulatory approval, we are following the FDA guidance that,
whenever possible, an investigational medicinal product should be used as
part of a clinical trial.
Unfortunately, not every patient who wishes to take part in a clinical trial will meet the eligibility criteria. The FDA facilitates an expanded access process, sometimes called “compassionate use”, as a potential pathway for a patient with animmediately life-threatening condition or serious disease or condition to gain access to an investigational medicinal product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
As a general policy, EHP does not currently provide access to its investigational products outside clinical trials for specific indications for which patients are required to meet certain eligibility criteria. We encourage patients to speak with their physicians and to participate in clinical studies.
EHP’s expanded access policy is in effect until sufficient information about a safe and efficacious dose regimen has been obtained in controlled clinical trials.
Therefore, EHP does not currently accept expanded access requests. We focus on the optimal design and conduct of our ongoing and future clinical trials, as well as the progress of our development programs, in order to accelerate future widespread access to patients.
If you have questions about EHP’s ongoing clinical trials or this expanded access policy, please contact EHP at email@example.com. Please expect a response within 5-10 business days.
Further information about EHP’s ongoing clinical trials is available on the NIH website http://www.clinicaltrials.gov.
As authorized by the FDA’s 21st Century Cures Act, EHP may revise this expanded access policy at any time.