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New Proposed Regulations Defining Donor Advised Fund Terms
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#WorkforceWednesday: AI Technology Regulations, Transparency in AI, OSHA's Permanent COVID-19 Standard - Employment Law This Week®
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Proposed EU Regulation on AI - Impact and Ripple Effect
More CBD Certainty: Clearing Confusion over Hemp in New York State
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Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more
During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...more
In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more
On December 7, U.S. Representative Greg Pence (R-IN) introduced the Innovative Feed Enhancement and Economic Development Act of 2023 (the Innovative FEED Act). Sen. Roger Marshall (R-KS) introduced the Senate version of the...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more
LEGISLATION, REGULATIONS & STANDARDS - Group Petitions USDA to Prohibit ‘Low-Carbon Beef’ Label, Require Verification for Carbon Claims - The Environmental Working Group (EWG) has petitioned the U.S. Department of...more
Legislators in California and New York have proposed bills to ban five food additives that have purportedly been linked to health concerns such as cancer, neurodevelopmental issues, and hormone dysfunction. The five...more
Over 50 years ago President Nixon declared a “War on Drugs,” leaving housewives over the country proclaiming marijuana to be the devil’s lettuce and urging sweet Billy to steer clear of the gateway drug...more
On February 23, 2022, the U.S. Food and Drug Administration (FDA) issued a proposed rule seeking to amend the medical device current good manufacturing practice requirements of the Quality System Regulation (QSR). Currently,...more
California and Vermont have recently joined a growing list of states that have passed legislation banning the use of per- and polyfluoroalkyl substances (PFAS) in food packaging. Relatedly, a group of environmental, consumer,...more
The U.S. Food and Drug Administration (FDA) indicated that the long-anticipated proposed rule modernizing the Quality System Regulation (QSR) is now targeted for release in April 2020. This is the second delay in the agency's...more
Seyfarth Synopsis: Through a reintroduced House bill, Congress is taking strides to push for cosmetic regulation reform and, separately, through the SAFE Act, it is seeking to establish a safe harbor for financial...more
In our first two Device Modernization series posts, we discussed FDA’s 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts to retool oversight of laboratory...more
In our first Device Modernization series post, we discussed how FDA is proposing to modernize the 510(k) review program. FDA also recently issued a proposed regulation for the De Novo program and linked that proposed...more
On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on behalf of drug manufacturers with...more
On January 8-9, 2015, the U.S. Food and Drug Administration (FDA) hosted a workshop to solicit public feedback on its proposed Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs). As background, the FDA...more