Here at Cytel, we are engaging in a small celebration this afternoon, as the US House of Representatives has just passed the FDA Reform Bill more generally known as the 21st Century Cures Act.
Although this bill is widely viewed as a reform bill, it will provide extensive funding to both the FDA and NIH to ensure that clinical and pharmaceutical research lives up to its potential to deliver life-saving technologies in a faster, smarter way.
Title II of the act contains approximately 150 pages on drug development. We're sure some of you have read it through and through. However, for those putting off their summer reading until August, here are 4 exciting developments that we want all of our friends and affiliates to be aware:
- Title II provides extensive stipulations for the future use of biomarkers and surrogate endpoints, as well as for the 'advancement of precision medicine.'
- We are also thrilled to note that 21st Century Cures provides a process for the expedited review of medical device technologies.
- The Act also aims to generate more debate on the use of clinical trials with adaptive and Bayesian designs, instructing the FDA to hold a public meeting and update its guidances.
- It makes specific reference to the importance of offering technical advice for modeling and simulation in adaptive trials.
For more information, you can find the act itself here.