Upping Your Game: Episode 1 – Meeting Hui Chen’s Challenge
Compliance Tip of the Day: AI and Compliance Education
The Next FCRA Frontier: Identity Theft and CFPB Updates — FCRA Focus Podcast
Daily Compliance News: April 29, 2025, The GenZ/RTO Edition
FCPA Compliance Report: From Compliance to Commercial Value: Removing Friction with AI
Compliance Tip Of the Day: Using AI to Transform Whistleblower Response
Episode 366 -- DOJ Issues Data Security Program Requirements
10 For 10: Top Compliance Stories For the Week Ending April 26, 2025
Compliance Tip of the Day: The Future of Continuous Monitoring
FCPA Compliance Report: Ellen Hunt on Compliance ROI and on a Due Diligence and the US Sentencing Guidelines
Compliance Tip of the Day: Leveraging AI for Real-Time Third-Party Risk Management
Navigating the Future of Payment Stablecoins: Legislative Updates and Market Implications — Payments Pros – The Payments Law Podcast
Navigating the Future of Payment Stablecoins: Legislative Updates and Market Implications — The Crypto Exchange Podcast
Compliance Tip of the Day: AI and Predictive Analytics
Exploring the Administration's Regulatory Impact on Private Equity — PE Pathways Podcast
Aligning Business Goals with Legal Strategies Amid Regulatory Change – Speaking of Litigation Video Podcast
Compliance Tip of the Day: Embedded Compliance
Shifting Gears: Adapting to Regulatory Changes in Auto Finance — Moving the Metal: The Auto Finance Podcast
Daily Compliance News: April 22, 2025, The Upping Your Game Edition
State AG Pulse | “Don’t Mess With Our Health or Our Kids!”
The U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration's (FDA) final rule on March 31, 2025, under which the FDA would have started regulating most laboratory-developed tests (LDTs)...more
Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...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
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
The FDA’s Webinar for Manufacturers and Other Interested Parties - The U.S. Food and Drug Administration (FDA) will host a webinar on February 25, 2025, from 2:00 p.m. EST to 3:00 p.m. EST, providing additional information...more
Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, diagnosis, and treatment of diseases, conditions, and infections. Examples of LDTs are the COVID-19...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
On May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach to oversight of laboratory developed tests (LDTs). The final rule is effective July 5, 2024....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
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
On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...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