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
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
Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with the with Phase 1 expectations under FDA’s Laboratory Developed Tests Final Rule (the “LDT Final...more
This year, we have seen several monumental events that already are, or potentially could be, pivotal to the future of the Laboratory Developed Test (“LDT”) industry – first, the issuance of the U.S. Food & Drug Administration...more
After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more
In this second installment of our nine-part deep-dive into the U.S. Food & Drug Administration (“FDA” or “the Agency”) final rule on Laboratory Developed Tests (“LDTs”) – which established a staged plan that will phase out...more
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more
On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) published its...more
Our FDA/Food, Drug & Device Team analyzes the practical considerations for adhering to the Food and Drug Administration’s final rule for laboratory-developed tests (LDTs)....more
The U.S. Food and Drug Administration's (FDA) recent announcement of a final rule extending regulatory oversight to laboratory developed tests (LDTs) has sparked controversy. As discussed in a previous Holland & Knight alert,...more
On April 29, 2024, FDA finalized the long-awaited rule to assert authority over the regulation of laboratory developed tests (LDTs) under FDA’s existing regulatory framework for medical devices under the Federal Food, Drug,...more
On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more