LathamTECH in Focus: Move Fast, Stay Compliant
Driving Digital Security: The FTC's Safeguards Rule Explained — Moving the Metal: The Auto Finance Podcast
The Labor Law Insider: NLRB Does a U-Turn on Make-Whole Settlement Remedies, Part II
Abortion Protections Struck Down, LGBTQ Harassment Guidance Vacated, EEO-1 Reporting Opens - #WorkforceWednesday® - Employment Law This Week®
The LathamTECH Podcast — Where Digital Assets Slot Into a Shifting Fintech Regulatory Landscape: Insights From the US, UK, and EU
Hot Topics in International Trade Terrified by Tariffs Braumiller Law
Navigating Contractor vs. Employee Classification
Wiley's 2025 Key Trade Developments Series: CFIUS Review and Outbound Investments
Wiley's 2025 Key Trade Developments Series: U.S.-Mexico-Canada Agreement (USMCA)
The Presumption of Innocence Podcast: Episode 60 - Enforcement Priorities of the Second Trump Administration: Employee Retention Tax Credit
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Non-Competes Eased, Anti-DEI Rule Blocked, Contractor Rule in Limbo - Employment Law This Week® - #WorkforceWednesday®
Business Better Podcast Episode - Manufacturing Moment: How State Associations Navigate the Policy Landscape
CHPS Podcast Episode 3: Unlocking America's Mineral Potential
Clocking in with PilieroMazza: Latest Developments on DEI Executive Order and Action Items before April 21 Deadline
Sunday Book Review: April 13, 2025, The Books on Trade and Tariffs Edition
Executive Actions Impact Federally Funded Research: What Institutions Should Do Now – Diagnosing Health Care Video Podcast
State AG Pulse | With the Reshaping of Government, More Power To State AGs
Consumer Finance Monitor Podcast Episode: A Deep Dive Into Judge Jackson’s Preliminary Injunction Order Against CFPB Acting Director Vought
AGG Talks: Home Health & Hospice Podcast - Episode 10: Anti-Kickback Compliance for Hospice and Skilled Nursing Providers
Following years of heightened concern about the dangers of exposure to ethylene oxide (EtO), increased regulatory oversight, and a steady hum of litigation, in 2025 it seems like things might be changing for the beleaguered...more
In the last years of the Biden Administration, the Federal Trade Commission issued a policy statement and sent letters to ten companies having Orange Book-listed patents claiming devices for administering drugs challenging...more
On January 14, 2025, the Biden administration’s U.S. Environmental Protection Agency (EPA) posted a last-minute “interim” decision in the Federal Register for its review of ethylene oxide (EtO) under the Federal Insecticide,...more
In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more
On January 6 and 7, 2025, the FDA announced, by our count, 31 draft or final guidances, on a wide range of topics. Historically, an incoming administration will impose a temporary freeze on the issuance of guidances and...more
On December 23, 2024, the Biden administration announced that the Office of the U.S. Trade Representative ("USTR") is launching a new investigation into China's trade practices with respect to the semiconductor industry. In...more
On October 10, 2024, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced its agenda of proposed guidance documents to be published or developed in the 2025 fiscal year (FY)....more
On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more
President Ronald Reagan famously quipped, "I think you all know that I've always felt that the nine most terrifying words in the English language are: I'm from the Government, and I'm here to help."1 At an Oct. 23-24, 2024,...more
On May 14, 2024, the Biden administration announced expansions to the United States’ Section 301 tariffs on imports from China, proposing to raise tariffs on solar panels, electric vehicles, batteries, green energy supply...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
It’s no secret that Democrats are traditionally trustbusters, but the Biden Administration is taking things to a whole new level, bringing novel—and arguably weak—cases that nonetheless slow or block tie-ups among healthcare...more
The Food and Drug Administration (“FDA” or “agency”) intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under the federal Food, Drug,...more
Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be available to manufacturers of medical...more
On January 30, 2023, the Biden administration announced its intent to end the national emergency and public health emergency (PHE) declarations on May 11, 2023. These emergency declarations have been in place since early...more
On January 4, 2023, the Biden Administration belatedly released the Fall 2022 Unified Agenda of Regulatory and Deregulatory Actions (the Unified Agenda). Typically published twice a year in the spring and the fall by the...more
Is it time for a glimmer of optimism about reducing at least one unacceptably high health care cost? Say hear, hear then, to the federal Food and Drug Administration’s removing the last regulatory block to...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights notable enforcement activity between April 21 and May 20, 2022, including a telemedicine case involving $64 million in false and fraudulent claims. We also...more
In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more
Last week, Diana DeGette (D-CO) and Fred Upton (R-MI) introduced in the House highly anticipated bill language for “Cures 2.0”, a follow-up to the transformational 21st Century Cures Act enacted in 2016... The 21st Century...more
In the past week, the FDA granted an EUA for the Pfizer-BioNTech vaccine for use in children 5–11 years of age. The agency also participated in the launch of the Bespoke Gene Therapy Consortium. The Administration held a...more
Last week, the White House COVID-19 Response Team encouraged school systems to implement a layered approach to prevention as schools return to in-person learning. Moderna submitted a Biologics License Application (BLA) for...more
The Biden Administration has taken (at least temporarily) the teeth out of a Trump-era Executive Order that directed the government to “Buy American” for essential drugs and medical devices. President Trump’s August 2020...more
In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS...more
Biden Administration Delays Effective Date and Opens Another Comment Period for New Medicare Coverage Pathway for Breakthrough Medical Devices and Definition of “Reasonable and Necessary” - To the dismay of the medical...more