Key expanded access strategies all companies should adopt
Recent conversation regarding expanded access has focused heavily on the [...]
Ways to make expanded access more appealing to pharmaceutical companies
Many proponents of Right to Try legislation believe that the [...]
The importance of Real World Data
Upcoming US legislation, known as the 21st Century Cures Act, [...]
Applying to an Institutional Review Board for an Expanded Access Program
Expanded Access Programs (EAPs), also known as Managed Access Programs, [...]
Charging for an investigational drug provided through an EAP
For some sick patients, receiving medication through an Expanded Access Program (EAP), also known as managed access, compassionate use, named patient, etc., is the only viable treatment option left. These programs allow the patients to gain access to investigational new drugs which are still in the clinical trial phase and are not, yet, licensed for use ...Read More
An EAP versus a clinical trial
Clinical trials have been conducted for decades, and, although people might not know the intricate ins and outs of how trials actually work, most people have at least heard of them. In comparison, Expanded Access, also known as Managed Access, Compassionate Use, Named Patient, etc. is a relatively new phenomenon. ...Read More