Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023

This bill would allow the FDA to quickly approve drugs, biological products, and medical devices already approved in certain countries (like EU nations or the UK) for use in the U.S., bypassing the standard U.S. review process. Manufacturers would request approval by providing proof of foreign authorization and demonstrating the product addresses an unmet medical need in the U.S. The FDA must decide within 30 days and can deny approval if safety concerns exist. This streamlines access to existing foreign-approved treatments for patients with urgent medical needs.