HR. 1632In Committee
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
Establishes a reciprocal approval pathway for drugs biological products and medical devices with qualifying foreign approval when there is an unmet medical need
Plain-English overview
What this bill does
Establishes a reciprocal approval pathway for drugs biological products and medical devices with qualifying foreign approval when there is an unmet medical need
Key points
- Establish reciprocal approval pathway
- Require sponsor eligibility showings
- Require FDA decisions in 30 days
- Allow FDA deny approval
Current status
Where it stands
Status
In Committee
Latest action
2025-02-26 — Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Related context
Topics and policy areas
undefinedCongressional oversightDrug safety, medical device, and laboratory regulationHealth