Lexology January 9, 2024
On January 5, 2024, the U.S. Food and Drug Administration (FDA) authorized Florida’s proposal under the Section 804 Importation Program (SIP) to allow Florida to proceed to the next steps in the regulatory process to import certain drug products that were approved by Health Canada. FDA’s authorization represents the Agency’s determination that the proposal meets the statutory standard for significant cost reduction without posing additional risk to health and safety. Nevertheless, Florida will still need to overcome several significant hurdles before it can begin to import any Canadian drugs. Accordingly, Florida still has a long way to go before importing any Canadian drugs, and litigation and other actions taken by certain stakeholders will likely further complicate, delay, and possibly even...
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