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.
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