Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
Changes in FDA, Cannabis Policies and AI Developments
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 181: South Carolina’s Life Sciences Economy with Ashely Teasdel, Deputy Secretary of SC Department of Commerce
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 166 — Christine Vannais, COO of Fujifilm Diosynth Biotechnologies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Episode 150 - Jane Pine Wood, Senior Vice President & Chief Legal Officer, BioReference
Jones Day Talks Health Care: The Eliminating Kickbacks in Recovery Act
In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more
On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more
On December 23, 2023, CMS issued its Final Rule, establishing new Clinical Laboratory Improvement Amendments (CLIA) regulations (the Final Rule). Several provisions only became effective December 28, 2024. CMS was driven to...more
On May 6, 2024 the FDA published its much-anticipated Final Rule on Lab-Developed Tests (“LDTs”) to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act (“FD&C...more
FDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) has been published in the Federal Register yesterday, May 6, 2024. This follows a decades-long effort by some stakeholders to clarify the regulatory status of...more
On December 5, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a final rule titled “Requirements for Medicare Incentive Reward Program and Provider Enrollment” (“the Rule”). The Rule implemented several...more