Reference listed drugs (RLDs) play an important role in the generic drug development process. These drugs are licensed and FDA listed, and are usually the originally produced drug that all generics, produced thereafter, have been compared to. In order for a generic drug to gain FDA approval, it will have to model the RLD in a number of ways. ...Read More
Expanded Access Programs (EAPs), also known as managed access, early access, compassionate use, named patient, etc. allow patients to be treated with investigational new drugs (INDs), which have not yet been approved, or drugs that have been approved but have limited availability. These patients are usually seriously ill and have run out of all other viable treatment options, including participation in a clinical trial. The intent of expanded access is to give these individuals and their families hope when all other avenues fail.....Read More
When a drug manufacturer is producing a new drug for market use, it will have to conduct a clinical trial in order to prove the safety and efficacy of its product. This is done by giving half of the trial subjects the new drug, and the other half a different product, and then comparing the effects. ...Read More