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Holland & Knight LLP

Recent FDA Actions Pose Big Changes and Questions for Health and Food Industries

Holland & Knight LLP on

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

McDermott Will & Schulte

Imported Drugs: (Possibly) Coming Soon to a State Near You

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

Jones Day

Reversal of Burden of Proof Under Proposal for a New EU Product Liability Directive

Jones Day on

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

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

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

McDermott Will & Schulte

Trending in Telehealth: June 6 – 12, 2023

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

McDermott+

McDermottPlus Check-Up: May 19, 2023

McDermott+ on

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

Sheppard Mullin Richter & Hampton LLP

PBM Practices Receive Increased Federal Scrutiny

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

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

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

Quarles & Brady LLP

Kentucky Board of Pharmacy Regulation Committee Proposes New Requirement of Licensure for All Out-of-State Pharmacists

Quarles & Brady LLP on

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

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - November 2019

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

Mintz - Health Care Viewpoints

Device Modernization Series: In Vitro Clinical Tests

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

Mintz - Health Care Viewpoints

Device Modernization Series: FDA’s Proposed De Novo Regulation

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

Latham & Watkins LLP

Drug Pricing and Payment Policy: Key 2018 Developments and Potential 2019 Changes and Challenges

Latham & Watkins LLP on

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

BakerHostetler

EPA to Propose Health Care Facility-Specific Regulations for the Management of Hazardous Waste Pharmaceuticals Under RCRA

BakerHostetler on

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

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