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 [...]
The national Right to Try bill was signed into law last month by President Donald Trump. The legislation intends to allow patients with no other treatment options available to them to try investigational drugs that [...]
On Wednesday of this week, President Donald Trump signed the national Right to Try bill into law. The Senate version of the bill was cleared by the House earlier this month, after much debate and [...]
Last week, President Trump’s administration released its new drug pricing plan, which calls for more competition and negotiation as well as greater incentives to lower list prices and out-of-pocket costs for patients. However, many commentators [...]