The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
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Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
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Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more
The U.S. Food and Drug Administration (FDA) is taking definitive steps to reinforce regulations surrounding laboratory-developed tests (LDTs). On September 29, 2023, the FDA announced its Proposed Rule seeking to clarify...more
After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory...more
THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more
Congress and federal agencies often engage in a game, each trying to see what the other is willing to do to achieve a particular policy or outcome. While Congress and federal agencies have unique authorities (legislative...more