In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
A November 6, 2019 decision by the United States District Court for the Southern District of New York vacated new rules promulgated by the Department of Health and Human Services (HHS) intended to protect medical providers...more