The fatal flaws in the 2023 CRA rule
Daily Compliance News: May 16, 2025, The Ethics Nightmare Edition
New York State Restaurant Reservation Anti-Piracy Act Cracks Down on a "Leech Industry"
Consumer Finance Monitor Podcast Episode: The Impact of the Election on the FTC
Compliance Tip of the Day: Standing at the Turning Point
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
AI Legislation: The Statewide Spotlight — The Consumer Finance Podcast
100 Days In: What Employers Need to Know - Employment Law This Week® - #WorkforceWednesday®
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Fair Lending Shake-Ups: CFPB Vacates Townstone Settlement, FHFA Ends GSEs' Special Purpose Credit Programs — The Consumer Finance Podcast
Brooklyn District Attorney Eric Gonzalez – Innovative Approach to Safety
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
Shifting Gears: Adapting to Regulatory Changes in Auto Finance — Moving the Metal: The Auto Finance Podcast
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Consumer Finance Monitor Podcast Episode: Everything You Want to Know About the CFPB as Things Stand Today, and Lots More - Part 2
Compliance into the Weeds: The Uncertain Future of Compliance Monitors under the Trump Administration
Cannabis Law Now Podcast - From Law Firm to Board Room: The Journey of a Cannabis Entrepreneur
Daily Compliance News: April 15, 2025, The Redefining Corruption Edition
Predictions regarding the 2023 CRA Rule and Section 1071 and how to prepare for expected developments
Evolving regulatory paradigms governing AI use in health care at the U.S. Food and Drug Administration (FDA) have set the pace for AI regulatory frameworks worldwide. Jodi Scott, partner in the Hogan Lovells medical device &...more
The Make America Healthy Again (MAHA) Commission, as established by President Donald Trump's Feb. 13, 2025, Executive Order (EO) 14212, released its inaugural report on May 22, 2025, titled "The MAHA Report: Making Our...more
On May 22, 2025, President Trump’s Make America Healthy Again (MAHA) Commission released an assessment titled “The MAHA Report: Make Our Children Healthy Again Assessment.” The report—framed as a “call to action”—stems from a...more
In his first major public remarks as commissioner of the U.S. Food and Drug Administration, Dr. Marty Makary laid out a comprehensive, reform-oriented vision for the agency during a fireside chat at the 2025 Food & Drug Law...more
On April 10, 2025, the US Food and Drug Administration (FDA) announced its intent to phase out the use of animal testing in the development of certain drugs and biologics. To help bring this “paradigm shift in drug...more
The U.S. Food and Drug Administration (FDA) recently announced it plans to phase out animal testing in the development of monoclonal antibody therapies and other drugs and biological products “with more effective,...more
In this episode of Holland & Knight's "The Eyes on Washington" podcast series, attorneys Rachel Gartner, Sara Klock, John Vaughan and Michael Werner discuss the evolving landscape of U.S. Food and Drug Administration (FDA)...more
In 2024, the Food and Drug Administration (FDA) significantly invested in reorganizing its internal infrastructure and enhancing operations. These efforts aimed to address the complexities of a global supply chain, rapid...more
Attend ACI’s 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products to stay ahead of the latest environmental and sustainability developments impacting cosmetics and personal care products...more
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more
Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more
Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more
Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more
The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more
On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based...more
The U.S. Food and Drug Administration (FDA) had regulated medical image analyzers for more than 20 years under the agency’s most stringent regulatory requirements. But the agency recently reclassified a subset of these device...more
The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain. The...more