The FDA has released its final guidelines on how to use real-world data and evidence.

The Guidance is an update to the 2021 draft guidance. It provides information about products used under an Emergency Use Authorization and the use of patient-level data from third parties.

The 21st Century Cures Act, which became law on December 13, 2016, was created to make medical product development faster and more efficient. Its goal is to bring new innovations and advances to patients who need them quickly. The Cures Act included a new section called 505F in the FD&C Act. The FDA made a framework called the Real-World Evidence (RWE) Program. This program helps evaluate if RWE can be used to support the approval of a new use for a drug that is already approved. It can also help meet post-approval study requirements. This is in response to the requirements in section 505F of the FD&C Act. In this program, we will discuss some important things to consider if you want to create a new registry or use an existing one to help make decisions about a drug's effectiveness or safety. This guidance does not tell you how to choose a study design or which statistical methods to use when analyzing data from registries.

Source: FDA