Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
From Permits to Penalties: A Deep Dive Into Coastal Development Law
PODCAST: Williams Mullen's Benefits Companion - Gag Clause Prohibitions
Cannabis Law Now Podcast - Cannabis in the Show Me State: An Interview with BeLeaf Medical's Mitch Meyers
Privacy for Risk Management: Bridge the Business, Technology and Compliance Gaps
Episode 374 -- Justice Department Resumes FCPA Enforcement with New, Focused Guidance
Cruising Through Change: The Auto-Finance Industry’s New Era Under Trump Unveiled — The Consumer Finance Podcast
2023 CRA Rule Repeal: Lessons to be Learned
The Classification of Gasoline & Gasoline Fumes as a Carcinogen: Considerations for Corporate Executives & Attorneys
Unlocking Crypto's Future: Insights From Coinbase's John D'Agostino — The Crypto Exchange Podcast
Hot Topics in International Trade - Let's Be Serious-Supply Chain Audits
Regulatory Rollback: Inside the CFPB’s FCRA Guidance Withdrawal — The Consumer Finance Podcast
Cruising Through Change: The Auto-Finance Industry’s New Era Under Trump Unveiled — Moving the Metal: The Auto Finance Podcast
Regulatory Rollback: Inside the CFPB's FCRA Guidance Withdrawal — FCRA Focus Podcast
Innovation in Compliance: The Critical Importance of Mobile Application Security: Insights from Subho Halder
2 Gurus Talk Compliance: Episode 53 – The AI as a Whistleblower Edition
Compliance Tip of the Day: Internal Controls for Third Parties
Healthcare Enterprise Risk Management
GILTI Conscience Podcast | Navigating Brazil's New Transfer Pricing Landscape: A Shift to OECD Standards
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