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Gardner Law

The Importance of a Clinical Trial Strategy

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Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

Jackson Lewis P.C.

Is the One Big Beautiful Bill Act an Employee Benefits Crystal Ball?

Jackson Lewis P.C. on

Takeaways- • Republicans in the U.S. House of Representatives attempt to deliver on President Trump’s campaign promises in the One Big Beautiful Bill Act (BBB or the Act), which passed the House by a razor-thin margin of...more

Paul Hastings LLP

Recent Investigations by the Texas Attorney General Piggyback on Federal ‘Make America Healthy Again’ Initiatives

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Texas Attorney General Ken Paxton recently announced that his office is investigating some of the country’s most ubiquitous home brands — including Colgate-Palmolive, Proctor & Gamble, and General Mills — for allegedly...more

Hogan Lovells

Be vigilant: new post-market surveillance requirements for medical devices in Great Britain take effect

Hogan Lovells on

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (PMSR), which were passed into law on 22 October 2024, came into force today (16 June 2025), amending the UK’s Medical...more

McGuireWoods LLP

Healthcare & Life Sciences Private Equity Deal Tracker: Everberg and 65 Equity Invest in Allied OMS

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65 Equity Partners and Everberg Capital have invested in Allied OMS, according to a news release. Allied OMS, founded in 2020 and based in Southlake, Texas, is a doctor-led management services organization supporting...more

Katten Muchin Rosenman LLP

FDA Reimagined: Faster, Friendlier, and Focused on Cures

On June 10, 2025, the Commissioner of the FDA, Dr. Martin Makary, and Dr. Vinayak Prasad, the Director of the FDA’s Center for Biologics Evaluation and Research, published an article in JAMA discussing the “Priorities for a...more

Benesch

Oregon Enacts Strictest Legislative Barrier on Private Equity Transactions in Healthcare

Benesch on

On June 9, 2025, Oregon enacted Senate Bill (“SB 951”). SB 951 significantly limits the ability of management services organizations (“MSOs”) and professional medical entities to engage in the traditional structures of...more

Rivkin Radler LLP

Quick Bites: Special Needs Planning

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If you have a loved one with special needs, you know that caring for him or her can, at times, feel totally overwhelming. Presumably, you have retained an attorney to guide you through the special education process in your...more

Foley & Lardner LLP

Indiana Adds More Restrictions on Physician Noncompete Agreements

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Last month we reported on physician and healthcare noncompete laws enacted in 2025. Shortly after the article was posted, another state joined the ranks: Indiana....more

Harris Beach Murtha PLLC

NY Department of Health Signals Costly Fines for Ignoring Staffing Issues

A COVID-era law targeting understaffing at health care facilities has seen its first significant settlement, serving as a signal to other New York facilities to address staffing issues in a timely manner or face fines....more

Davis Wright Tremaine LLP

Washington Employment Law Mid-Year Update for 2025

Several key bills passed during the recent Washington legislative session that will significantly impact Washington employers...more

DLA Piper

GAO Report Gives MA Organizations and Behavioral Health Providers Food for Thought on Prior Authorization

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The US Government Accountability Office (GAO) recently released a report on the Centers for Medicare and Medicaid Services (CMS)’s oversight of prior authorization criteria for behavioral health services (BHS) by Medicare...more

McDermott+

McDermott+ Check-Up: June 13, 2025

McDermott+ on

THIS WEEK’S DOSE - - Reconciliation Moves Forward. Senate committees continue to release their reconciliation provisions. - NIH Director Testifies on FY 2026 Budget. National Institutes of Health (NIH) Director Bhattacharya...more

A&O Shearman

Council position on EU pharma package adopted

A&O Shearman on

On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package’. The pharma package now moves to the next...more

Bass, Berry & Sims PLC

New Tennessee Law Eases Physician Employment Restrictions for Certain Hospitals

Bass, Berry & Sims PLC on

On May 21, Governor Bill Lee signed House Bill 979 (HB 979) into law.  Notably, provisions of this law aim to address physician shortages and improve access to specialized medical care in rural and underserved areas in...more

Benesch

Dialysis & Nephrology Digest - June 2025

Benesch on

Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more

Robinson+Cole Environmental Law +

Navigating OSHA’s Updated Inspection Strategy

In May 2025, the Occupational Safety and Health Administration (OHSA) released an updated Site-Specific Targeting (SST) Inspection Program directive. The SST Inspection Program is OSHA’s main site-specific programmed...more

DLA Piper

Food and Beverage News and Trends - June 2025 #2

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. On June 9, HHS Secretary Robert F. Kennedy, Jr., announced that he is “retiring”...more

Venable LLP

Marketing in Sensitive Sectors: The FTC Prescribes a $1.9 Million Lesson to Evoke Wellness

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Federal Trade Commission (FTC) chairman Andrew Ferguson has promised vigorous law enforcement under his leadership. Consistent with that promise, on June 10, 2025, the Commission announced a $1.9 million settlement with...more

Knobbe Martens

Federal Circuit Review | May 2025

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In Jazz Pharmaceuticals, Inc. v. Avadel Cns Pharmaceuticals, LLC, Appeal No. 24-2274, the Federal Circuit held that injunctions prohibiting the initiation of new clinical trials for paper NDA drugs before patent expiration...more

JUSTICENTER

The Emotional Impact of Car Accidents

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Most people think of broken bones and totaled cars when they imagine a car accident. But the damage often goes deeper than what we can see. The emotional and psychological toll of a crash can be just as serious as physical...more

Cozen O'Connor

The State AG Report – 06.12.2025

Cozen O'Connor on

Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: • Connecticut Law Aims to Weed Out Illegal Sales of...more

Katten Muchin Rosenman LLP

FTC and DOJ Announce Listening Sessions on Lowering American’s Drug Prices

On April 15, 2025, President Donald Trump issued  Executive Order No. 14273, “Lowering Drug Prices by Once Again Putting Americans First, ” which outlines a series of targeted actions to lower prescription drug costs and...more

Stevens & Lee

Navigating Interstate Entity Issues: Corporate Practice of Medicine and Ownership Considerations

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Health care entities, such as professional corporations (PCs) and professional limited liability companies (PLLCs) (known as “restricted limited liability companies” in Pennsylvania), encounter a complex legal analysis when...more

Hendershot Cowart P.C.

Legal Remedies for Physicians When Medical Billing Companies Fail to Perform

Hendershot Cowart P.C. on

For physicians with independent practices, engaging a third-party billing company to manage the billing process is an attractive option. Medical billing is increasingly complex and time consuming, and outsourcing that...more

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