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 [...]
Over the past decade, regulators and healthcare authorities have become increasingly aware of the important role that patients can play in developing new medicines and getting them to market. In light of this, in new [...]
With the Brexit leave date fast approaching, efforts are continuously being made to ensure that patient health and wellbeing remain protected, following the UK’s exit from the EU. Last month, the Secretary of State for [...]
In a move that defies President Trump’s proposed budget for fiscal 2019, the Senate is gearing up to approve a $2 billion increase in funding for the National Institutes of Health (NIH). This increase has [...]