The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
Both chambers of Congress are out of session today and return for the rest of the week. Most healthcare priorities remain out of the congressional spotlight this week, but telehealth is still top of mind. As we...more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
Happy New Year! As we enter 2024, we want to lay out some of the main regulatory issues (both new and old) that McDermott+Consulting will be tracking over the next year. While these may evolve, we think they are still...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
Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more