Since 1984, the “Chevron doctrine” had served as the bedrock of many regulatory actions by the U.S. Department of Health and Human Services (HHS) and other federal agencies. Under the doctrine, courts followed a two-step...more
On December 18, 2019, in a reversal of historic and substantive reservations, the U.S. Food and Drug Administration (FDA or Agency) issued a notice of proposed rulemaking (Proposed Rule) that, if finalized, would allow for...more
In 2009, the United States Supreme Court in Wyeth v. Levine affirmed a judgment rejecting a prescription drug manufacturer’s contention that plaintiff’s claim that the manufacturer should have strengthened its U.S. Food and...more