Faster Access to Foreign-Approved Drugs 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 for marketing in other countries. This means citizens could get quicker access to new, potentially life-saving treatments available abroad, provided they meet strict safety requirements.
Key points
Allows for faster U.S. market approval of drugs and medical devices already legally sold in select countries, such as the United Kingdom.
Requires that these products address a public health or unmet medical need in the United States.
The FDA will still assess the safety and effectiveness of these products, with the power to deny approval or require additional post-market studies.
Congress has the ability to disapprove an FDA decision to deny a product, providing an additional layer of oversight.
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