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 [...]
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 [...]
WEP Clinical LTD (WEP), a specialist services company that works with drug developers to help patients and physicians gain early access to medicines when no other treatment options are available, has partnered with biopharmaceutical [...]
WEP Clinical (WEP) is pleased to announce a new partnership with Y-mAbs Therapeutics, Inc. (Y-mAbs), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. [...]
WEP Clinical LTD (WEP), a specialist services company that works with pharmaceutical companies to help patients and physicians gain access to medicines when no other treatment options are available, has partnered with TaiMed Biologics [...]
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, [...]
Upcoming US legislation, known as the 21st Century Cures Act, will incorporate more of the patient experience into drug development. There will be a focus on structured collection of data from patients about the personal [...]
Expanded Access Programs (EAPs), also known as Managed Access Programs, help sick patients gain access to drugs that are not available through traditional access routes. These can be drugs that are still in development, in [...]
