SkadBytes Podcast | Tech’s Shifting Landscape: Five Trends Shaping the Conversation
Unlocking Crypto's Future: Insights From Coinbase's John D'Agostino — The Crypto Exchange Podcast
State AG Pulse | A FAIR Go For NY Consumers
Under the Hood: Exploring the CFPB's 2025 Focus — Moving the Metal: The Auto Finance Podcast
State AG Pulse | “Don’t Mess With Our Health or Our Kids!”
The Presumption of Innocence Podcast: Episode 59 - Enforcement Priorities of the Second Trump Administration: DOJ Focus
Consumer Finance Monitor Podcast Episode: Everything You Want to Know About the CFPB as Things Stand Today, and Lots More - Part 1
State AG Pulse | With the Reshaping of Government, More Power To State AGs
2024 Credit Reporting Review: Impactful Changes and Future Forecast — FCRA Focus Podcast
You've got Questions
Through the Crystal Ball: What's Next for Auto Finance — Moving the Metal: The Auto Finance Podcast
State AG Pulse | DEI in the Federal and State Spotlight
Are Overtime Wages and Tips Exempt From Income Tax? What Employers Need to Know to Prepare
The Labor Law Insider: What's Next for Labor Law Under the Trump Administration, Part II
Weathering the 2025 Whirlwind: How to Keep Calm & Carry On
2024 in Review: Major Debt Collection Trends and 2025 Outlook — The Consumer Finance Podcast
#WorkforceWednesday®: Workplace Law Shake-Up - DEI Challenges, NLRB Reversals, and EEOC Actions - Employment Law This Week®
FTC Regulatory and Enforcement Shifts Under New Leadership
7 Key Takeaways | The Changing Landscape of Federal Funding in the Trump Administration
Bipartisan Leadership and Reform at NAAG: Insights From Brian Kane — Regulatory Oversight Podcast
As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early...more
Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more
Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics. For pharmaceutical and medical device companies, AI-driven solutions present...more
On March 17, 2025, the government published a policy paper with an Action Plan for regulation and regulators, outlining how it intends to reform the UK's regulatory system to support growth and innovation. The Action Plan...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
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more
On December 28, 2024, Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages (see our previous article regarding Health Canada’s...more
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more
Based on recent policy signals and statements from incoming administration officials, a picture of potential regulatory and policy changes that could affect biotech, pharmaceutical, and medical device companies in coming...more
On December 28, 2024, Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments to the Food and Drug Regulations, CRC, c 870 and the Medical Devices...more
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more
China's State Administration for Market Regulation (SAMR) has released the draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (Draft Guidelines) for public comment. The Draft Guidelines,...more
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more
Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more
In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more
The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more
The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more
On September 29, 2023, the Food and Drug Administration (FDA) issued a proposed rule that would end its long-standing policy of enforcement discretion with respect to regulation of laboratory-developed tests (LDTs) (the...more
Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more
Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more
The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an...more