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S 3081119th CongressIn Committee
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
Introduced: Oct 30, 2025
Sponsor: Sen. Cruz, Ted [R-TX] (R-Texas)
Standard Summary
Comprehensive overview in 1-2 paragraphs
Establishes reciprocal marketing approval process for drugs, biological products, and devices already approved in certain foreign countries.
Key Points
- 1Creates 30-day review process for foreign-approved products
- 2Covers products from specified countries and UK
- 3Requires demonstration of public health need
- 4Allows FDA to impose postmarket study conditions
- 5Includes congressional disapproval mechanism
- 6Mandates outreach to potential sponsors
Impact Areas
Pharmaceutical regulationMedical device approvalInternational regulatory cooperationPatient access to treatmentsFDA oversight
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