Enhancing Patient Care with Real-World Evidence

The 21st Century Cures Act of December 2016 was a turning point in the development of RWE (Real World Evidence) in the United States. Prior to the Act, FDA’s primary use of RWE was in the post-approval safety surveillance of products that were already in the market The Act added section 505F to the Federal… Continue reading Enhancing Patient Care with Real-World Evidence