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Faster Access to Foreign-Approved Medicines and Medical Devices

This act aims to speed up access to drugs, biological products, and medical devices in the U.S. that are already approved and legally marketed in certain countries, such as the United Kingdom. This means citizens could get quicker access to new, potentially life-saving treatments already available abroad, provided they meet specific safety and medical need criteria.
Key points
Drugs and medical devices approved in the UK or other specified countries can be marketed faster in the U.S.
Approval decisions will be made within 30 days, significantly reducing waiting times.
The FDA can deny approval if a product is deemed unsafe or ineffective, ensuring patient safety.
The act aims to address unmet medical needs and improve public health in the U.S.
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Additional Information
Print number: 117_S_154
Sponsor: Sen. Cruz, Ted [R-TX]
Process start date: 2021-02-02