The growing complexity of clinical trials is stretching research sites to their limits, as they struggle with dwindling resources, recruitment challenges, and the rapid adoption of new technologies. To stay ahead, sites need to pinpoint [...]
Introduction Early Access Programs (EAPs) in France provide pharmaceutical and biotech companies with a valuable opportunity to offer patients innovative treatments before obtaining formal marketing authorization. Regulated by the French National Agency for the Safety [...]
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 [...]
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 [...]
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
