> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Bipartisan Real-World Evidence Legislation Introduced
- URL: https://www.fdaweb.com/bipartisan-real-world-evidence-legislation-introduced/
- Published: 2021-05-05T12:00:00.000Z
- Updated: 2026-09-14T16:57:35.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5149253

Three U.S. senators have introduced S.1508 (text not yet available) to “harness real-world evidence (RWE) gathered during emergency use authorization to support future approvals for drugs, biologics, and medical devices at FDA.” The bill is sponsored by Sens. **Roger Marshall** (R-KS), **Tina Smith** (D-MN), and **Bill Cassidy** (R-LA).

A [statement](https://www.marshall.senate.gov/press-releases/sens-marshall-smith-cassidy-join-forces-to-harness-real-world-evidence-in-fda-approval-process/?ref=fdaweb.com) issued by Marshall on behalf of all three sponsors says the [legislation](https://www.congress.gov/bill/117th-congress/senate-bill/1508/all-info?ref=fdaweb.com) would enable FDA to develop a clear framework for how it uses RWE in premarket approvals ranging from drugs and vaccines to medical devices.

“Not only will this help with clinical decision-making and making practice adjustments during a pandemic,” the three say, “this legislation could also help in shortening the length of time it takes for FDA to approve a product and could help in reducing the cost for medical innovators to bring a product to market.”