RMAT Designations: Lessons Learned on the Clinical Evidence Requirement

The 21st Century Cures Act (Cures Act), signed into law in December 2016, was designed to reduce regulatory obstacles for FDA approval of innovative medical therapies and accelerate the process of bringing innovative products to patients in need. Included in the Cures Act was a pathway to accele Powered by WPeMatico Continue reading RMAT Designations: Lessons Learned on the Clinical Evidence Requirement

FDA’s $100 Million Real-World Evidence Project: Making It All It Can Be

Paul Glimcher In a sign of the increasing role real-world evidence (RWE) will have in healthcare research, FDA recently announced a $100 million proposal to build a modern system to gather RWE from about 10 million individuals. The good news is that this could transform clinical trials Powered by WPeMatico Continue reading FDA’s $100 Million Real-World Evidence Project: Making It All It Can Be