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Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential...
Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential...
Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for...
Last week we saw an article on a baseball website about batters who, through umpire forgetfulness or whatever, were not called out until strike four. Then we read Comatov v. Medtronic,...
On January 31, 2020, in response to the COVID-19 pandemic, the Secretary of Health and Human Services (HHS) issued a declaration of a public health emergency (PHE) under Section...