What is so Controversial About RWE?

The U.S. House of Representatives has overwhelmingly passed the 21st Century Cures Act, moving it on to the Senate for approval. A very important and controversial piece of this legislation includes the use of real world evidence in the approval process. Patient advocacy groups say this will help get cures to patients quicker. Opponents argue the FDA already moves faster than other countries and the use of RWE instead of clinical trials would lead to safety concerns. Read more here. (Source: Managed Care)