Categories: FDA, Health Care, Life Sciences

New from the Diagnosing Health Care Podcast: Laboratories in the United States are facing a major regulatory landscape shift.

The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory developed tests (LDTs). What does this mean for labs going forward?

On this episode, Epstein Becker Green attorneys James Boiani, Rob Wanerman, and Megan Robertson lay out the new landscape, analyze existing and potential challenges, and identify key developments to watch for as this new regulatory era unfolds.

About the Diagnosing Health Care Podcast

What health care and life sciences decision-makers need to lead, comply, and compete. The health care industry is full of high-stakes legal, policy, and regulatory obstacles. And significant opportunities for those prepared to act on them. Diagnosing Health Care® delivers the intelligence executives, general counsel, and administrators need to navigate both. Part of the Epstein Becker Green Insights Network.

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Tags: Diagnosing Health Care Podcast, FDA, laboratory developed tests, LDTs, Podcast
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