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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
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
In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....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
Trending in Telehealth is a new series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies,...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
Though many recent reforms regarding prescription drug affordability have been focused on manufacturers and health plans, pharmacy benefit managers (“PBMs”) are also the focus of increased attention from federal policymakers...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more
On March 15, 2022, the Regulation Committee for the Kentucky Board of Pharmacy reviewed potential amendments and proposed regulations governing non-resident pharmacy licensure in the state. Among the proposed changes is a...more
Congress returns to Washington this week after the Thanksgiving recess to find a feast of leftover legislative items still on the table. Congress has a limited number of days remaining on the 2019 legislative calendar to...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
Following a number of drug pricing reforms implemented or proposed in 2018, 2019 likely will bring more action from HHS and Congress to reduce drug prices. Key Points: ..In 2018, the Administration implemented and...more
EPA plans to propose new regulations this year to address the management of hazardous waste pharmaceuticals under the Resource Conservation and Recovery Act (RCRA). The agency anticipates issuing a notice of proposed...more