HR 1632 · 119th CongressIn Committeecongress.gov ↗
What this bill does
AI plain-language summaryThis bill creates a new way for drugs, biological products, and medical devices to be sold in the United States even if they haven't been approved by the FDA. If a product is already approved in certain other countries and there is an unmet medical need for it, the company can ask for "reciprocal approval" to sell it here. The FDA must decide within 30 days whether to approve the request, and can say no if they think the product isn't safe or effective. If the FDA says no, Congress can pass a joint resolution to approve the product anyway.
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