Lexology December 20, 2023
At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially with 2022 having been a reauthorization cycle for the largest medical product user fee programs relied upon by FDA. Unexpectedly – following a successful legislative cycle that culminated with enactment of the FDA User Fee Reauthorization Act of 2022 on September 30, 2022 – the agency also ended that year with what we called a “holiday present from Congress” when it received a slew of new authorities and mandates through the Food and Drug Omnibus Reform Act (FDORA). FDORA was signed into law...
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