Pipeline · Bill → Law
Step 1
Introduced
May 18, 2023
Step 2
Referred
May 19, 2023
E&C · Rules
Step 3
Committee
Step 4
House floor
Step 5
Senate
Step 6
Resolve Changes
Step 7
Signed
SummaryCRS Summary
This bill establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country and there is an unmet need. Specifically, in order to receive reciprocal approval, the bill requires the product's sponsor to demonstrate, among other things, that (1) the product has been approved in one of the specified countries, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the pro...
Timeline · 4 actions
May 19, 2023
Referred to the Subcommittee on Health.
May 18, 2023
Introduced in House
May 18, 2023
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.
May 18, 2023
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.