FDA has issued final guidance on how to submit real-world data and evidence in filings

On September 8, the U.

The guidelines apply to applications that contain research-based new drug applications (INDs), new drug applications (NDAs), and biological product licensing applications (BAs) designed to support regulatory decisions regarding product safety and/or efficacy

The Guidelines are one of several guidances issued by FDA for the development of RWE under the 21st Century Medicine Act, which was originally published in May 2019, and the Final Guidance modifies some of the wording of the draft to further clarify what

In accordance with the final guidelines, fda recommends that sponsors and applicants do not identify the filing as containing RWD/RWE if the data for RWD/RWE

FDA recommends that sponsors include the following specific information in their reporting cover letters containing RWD/RWE that support product labeling:

Use RWD/RWE for purposes

Use RWD to generate RWE study designs

The RWD source used to generate the RWE

Examples listed by the FDA for the purpose of using RWD/RWE are: supporting the safety and/or efficacy of products that have not previously been approved by the FDA; Support labeling changes for FDA-approved products (including, but not limited to: adding or modifying indications, changing dosages, dosing regimens, or routes of administration, extending product labeling indications to new populations, adding comparable efficacy information, adding or modifying safety information, other proposed labeling changes), and helping to support or meet post-market requirements or post-market commitments