On March 10, 2025, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced in a press release that he has directed the Food and Drug Administration (FDA) to explore rulemaking to implement a...more
FDA will hold a webinar regarding the proposed rule, which reiterates FDA’s assertion of jurisdiction over laboratory developed tests and proposes a phaseout of its general enforcement discretion approach.
On October 31,...more