US congressmen head initiative to improve clinical trial process

Fred Upton, chairman of the House Energy and Commerce Committee, and Rep. Diana DeGette have recently launched the 21st Century Cures initiative, a bill intended to improve clinical trials and expedite the drug and device approval process. Upton and Degette plan to...

FDA issues final guidance document on IDE submission decisions

FDA has released a new final guidance document supporting clinical studies of new medical devices under their Investigational Device Exemption (IDE) regulations. In order to conduct clinical trials on investigational products, medical device companies must submit an...

EU hopes to increase clinical trial applications with new legislation

The European Union (EU) recently published over 70 pages of legislation to conclude the long, exhaustive effort to remedy their old system of clinical trial regulations. Daniel Cressey’s article on nature.com highlights important takeaways from the legislation as well...