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 [...]
Providing home nursing support can be hugely beneficial for sponsors carrying out clinical trials. Moving away from the traditional clinical trials sites and, instead, administering treatment and monitoring patients their own homes reduces the burden [...]
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 [...]
Rare Disease Day 2020 will be held this week, on Saturday the 29th of February. Occurring every year on the last day of February, this day is celebrated to help raise awareness of rare diseases [...]
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 [...]
In recent years, there has been increased recognition of the important role that patients can play in enhancing drug development and approval efforts. Because patients are experts in their disease area, they can provide useful [...]
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 [...]