FKH has been working with Idis (see case study here) for the past 4 years to help educate audiences and raise awareness of the benefits of expanded access programs (EAPs). EAPs enable patients who have exhausted all other options to potentially gain access to drugs prior to their approval or launch, in full compliance with regulatory guidelines.
Patients, advocates, and physicians frequently seek access to medicines outside the well-established clinical trial and commercial framework. EAPs are an important option for companies as they help such patients.
- John Lagus, Vice President, Business and Corporate Development, Idis
- Sue Barrowcliffe, Global Director of Regulatory and Medical Strategy, Idis
- Richard Klein, Public Health Specialist, Office of Special Health Issues, OC, FDA
This webinar provides important information and best practices on these programs that allow patients with unmet medical needs to gain access to medicines outside the traditional clinical and commercial framework. Registration can be completed online here.