S 3081 · 119th CongressIn Committeecongress.gov ↗
What this bill does
AI plain-language summaryThis bill creates a new, faster way for drugs, biological products, and medical devices to be sold in the United States even if they haven't gone through the regular FDA approval process. If a product has already been approved in certain other countries and there is an unmet medical need for it, the product's maker can apply for this special approval, and the FDA must make a decision within 30 days. The FDA can still say no if it believes the product isn't safe or effective, and it can require additional studies after the product goes on the market. If the FDA does turn down a product through this process, Congress can pass a resolution to approve it anyway.
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