Where Can an Expanded Access Program Fit Into the Drug Development Process? Expanded Access Programs (EAPs) provide patients access to investigational drugs outside of the clinical trial setting. These programs provide promising new medicines to patients [...]

When is Compassionate Use a Viable Option? Compassionate use refers to the use of an unapproved drug to treat a patient, outside of a clinical trial setting, when no other viable treatment options are available. [...]

Why Might Companies Refuse to Provide Expanded Access 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 [...]

What Patients are Eligible for Pre-Approval Drug Access? 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 [...]

Three Things Patients Should Know About Companies Providing Expanded Access Use of their Investigational Drugs Expanded Access Programs (EAPs), also referred to as Managed Access or Compassionate Use Programs, allow patients with no viable treatment [...]

Key Expanded Access Strategies All Companies Should Adopt 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 [...]

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