Expanded Access Programs (EAPs) provide patients access to investigational drugs outside of the clinical trial setting. These programs provide promising new medicines to patients suffering from cancer or rare diseases who have no other [...]
The House committee has advanced a new bill aiming to close a loophole in the Orphan Drug Act and increase market competition for prescription drugs. The Orphan Drug Act was passed in 1983 to [...]
In recent years, industry has been looking for ways to modernize the traditional clinical trial model. As such, companies are now being encouraged to try methodologies and strategies that will streamline processes and introduce [...]
The European Commission, which is the executive branch of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU, has been working with EU [...]
As the UK officially left the EU at the end of last month, Brexit is now well underway. The country is currently in the midst of an 11-month transition period, during which the government will [...]
Although the UK is home to some of the world’s leading scientific and medical researchers, the country has historically struggled to make effective use of large-scale patient health data. In an effort to combat this, [...]
The Orphan Drug Act (ODA), which was passed in 1983 to incentivize drug development for rare diseases, has come under scrutiny in recent years. There are some within industry who claim that the program has been [...]
The FDA has recognized the important role that real-world evidence (RWE), i.e. evidence that is collected outside the tightly controlled clinical trial setting, can play in furthering drug development and facilitating drug approvals. In line [...]
The goal of the FDA is to ensure that patients can access needed medicines in a safe and compliant manner, and the agency will support any legislation that aims to further this. As such, although [...]
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 outside of the clinical trial setting. However, like [...]