Early Access Programs allow patients and physicians to use investigational (pre-approval) drugs outside the clinical trial setting. They are often referred to as Expanded Access Programs (EAPs), Compassionate Use Programs (CUPs), or Managed Access [...]
Compassionate use is a term used to describe the provision of an unauthorized medicine when it is given to a patient at no cost. This usually occurs when a drug company recognizes there is [...]
WEP Clinical, the specialist pharmaceutical services company, is proud to serve the rare disease community across the globe. As part of our overall mission to help patients get access to medicines and, ultimately, transform [...]
After Right to Try legislation was passed in the US earlier this year, many believe that desperate patients will now find it easier to try investigational products outside of the clinical trial setting. However, like [...]
Patients suffering from rare diseases or life-threatening illnesses, like cancer, can often find that there are very few treatment options available to them. For these patients, accessing an investigational drug outside of the clinical trial [...]
Recently approved legislation, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017”, allows patients in the US the ability to request access to investigational drugs, without any approval or [...]
Randomized controlled trials (RCTs) have long served as the gold standard for developing and assessing new drugs and devices. However, over the past couple of years, there has been a real push towards collecting and [...]
Expanded Access Programs (EAPs), also referred to as Managed Access or Compassionate Use Programs, allow patients with no viable treatment options available to them to access investigational drugs before they are approved for market use. [...]
Recent conversation regarding expanded access has focused heavily on the necessity of the FDA approval process. Right to Try legislation, which would remove the FDA from the expanded access process in the US, has been [...]
Many proponents of Right to Try legislation believe that the US Food and Drug Administration (FDA) is too slow and inefficient when it comes to reviewing requests for access to important investigational new drugs. They, [...]
