FDA announces changes to requirements for section 804 importation program proposals

The U.S. Food and Drug Administration updated requirements for states and tribes developing proposals for state import programs. A July 1, 2025 post clarifies that applicants can use "a static baseline approach for the cost-savings analysis" instead of trying to account for changes  in unpredictable markets.

The agency also posted an email for states to request informational meetings before they submitted their proposals.

Read the update here.

 

 

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