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Hogan Lovells

FDA finalizes RRA manufacturing inspection guidance as US focuses on supply chain security

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The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records request authority and virtual...more

Foley & Lardner LLP

FDA: Commissioner’s National Priority Voucher Program Aims to Streamline Some Drug Reviews

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Share on Twitter Share by Email Share Back to top The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, via a press release accompanied by a list of...more

King & Spalding

Trump Administration Revamps Working Group to Focus on False Claims Act

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On Wednesday, July 2, 2025, HHS and DOJ announced a new working group focused on enforcement of the False Claims Act (“FCA”). According to the announcement, the DOJ-HHS False Claims Act Working Group (“Working Group”) is a...more

Foley & Lardner LLP

Gender-Affirming Care: Key Takeaways from FTC’s July 2025 Workshop on Unfair Or Deceptive Trade Practices

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On July 9, 2025, the Federal Trade Commission (FTC) hosted a workshop focused on perceived “dangers” arising from unfair or deceptive trade practices in marketing a variety of health care services falling under the label of...more

Foley & Lardner LLP

The Patent Eligibility Restoration Act and Life Sciences Innovation

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The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based...more

Cranfill Sumner LLP

Navigating Stark Law and the Anti-Kickback Statute (AKS) in 2025: A Snapshot Guide for Medical Practices

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In today’s healthcare environment, compliance with federal regulations is more than a legal necessity—it’s a cornerstone of ethical and sustainable practice management. Two of the most critical laws that medical practices...more

Epstein Becker & Green

Latest Moves by Federal Agencies Regarding Gender-Affirming Care: Risks Mount for Providers

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Since day one, a policy priority of the Administration has been to discourage and prevent gender-affirming care for children and adolescents that involves surgery or medication....more

Arnall Golden Gregory LLP

CMS Announces Changes for SNFs on Care Compare Website

The Centers for Medicare & Medicaid Services (“CMS”), Center for Clinical Standards and Quality recently announced upcoming changes to skilled nursing facility (“SNF”) profiles on the Medicare Care Compare website. Care...more

Alston & Bird

Health Care Week in Review | HHS Blocks Access to Select Federal Health Programs for Undocumented Individuals; Senate HELP...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Polsinelli

EKRA Gets Teeth: Ninth Circuit Strengthens EKRA Enforcement in Schena Ruling

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Key Takeaways - First Appellate Interpretation of EKRA: The Ninth Circuit’s decision in United States v. Schena marks the first appellate court interpretation of the Eliminating Kickbacks in Recovery Act (EKRA), affirming...more

FordHarrison

Changes To Texas Noncompete Rules for Physicians and Certain Other Healthcare Providers Effective September 1, 2025

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On June 20, 2025, Texas Senate Bill 1318 was signed into law, introducing new restrictions on noncompete agreements entered with physicians licensed by the Texas Medical Board and other healthcare practitioners in Texas....more

Epstein Becker & Green

The Record-Setting First National Health Care Fraud Takedown of the Second Trump Administration: What Stayed the Same and What is...

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On June 30, 2025, the U.S. Department of Justice (“DOJ”), together with the U.S. Department of Health and Human Services Office of Inspector General (“HHS OIG”) and other law enforcement partners, announced the results of the...more

Polsinelli

Needle Little Regulation: What Texas’s New IV Therapy Law Really Says

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Key Takeaways - House Bill 3749, also known as Jenifer’s Law, goes into effect on September 1, 2025, and applies only to elective IV therapy provided outside physician offices or licensed health facilities....more

Venable LLP

Spotlight On: Biosimilar Litigations - July 2025

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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Goodwin

DOJ and FTC Host ‘Listening Sessions’ on Competition Issues in the Pharmaceutical Industry

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In two recent public panels, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) hosted the first of three joint listening sessions mandated by Executive Order No. 14273, Lowering Drug Prices by Once Again...more

DLA Piper

Keeping Watch on the IRA: Co-pays Increasing for Diabetes Medications

DLA Piper on

The Inflation Reduction Act (IRA) made changes to the way drugs are covered and reimbursed in Medicare. It has been anticipated that this could result in more restrictive formularies in drug plans or higher co-pays for...more

Alston & Bird

Getting the Band Back Together: DOJ and HHS Launch New False Claims Act Enforcement Working Group

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The Department of Health and Human Services and the Department of Justice have formed a False Claims Act (FCA) enforcement working group to target health care fraud. Our Health Care Litigation Group highlights what industry...more

Venable LLP

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) /...

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Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Jones Day

CMS Updates Kidney Care Choices Model

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The Center for Medicare and Medicaid Innovation ("CMMI") announced sweeping changes to the Kidney Care Choices Model ("KCC Model"), a key set of value-based programs....more

Holland & Knight LLP

One Big Beautiful Bill Act Includes $50 Billion Rural Health Transformation Program

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President Donald Trump signed H.R. 1, known as the One Big Beautiful Bill Act (OBBB), into law on July 4, 2025. (For a detailed analysis of the bill, see Holland & Knight's previous alert, "Trump Signs the One Big Beautiful...more

Troutman Pepper Locke

Exclusive Licensing May Offer Biotechs a Financial Lifeline

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With volatile market conditions and recent FDA shakeups, biotech companies are increasingly focused on bolstering cash runways and accelerating R&D efforts. But fierce competition for financing has some biotechs turning to...more

Sheppard Mullin Richter & Hampton LLP

DOJ and HHS Announce Joint False Claims Act Working Group and Enforcement Priorities

On July 2, 2025, the Departments of Justice and Health & Human Services announced a joint working group aimed at “strengthening their ongoing collaboration to advance priority enforcement areas” under the False Claims Act...more

Eversheds Sutherland (US) LLP

One not-so-big summary of the compensation and benefits law changes in the One Big Beautiful Bill Act

The One Big Beautiful Bill Act (Act), signed into law on July 4th, contains a number of provisions that will impact employee compensation and benefits. Employers and service providers should start considering the following...more

Sheppard Mullin Richter & Hampton LLP

Texas Enacts Massive Reforms to Healthcare Provider Non-Competes

Beginning September 1, 2025, Texas will significantly narrow the permissible scope of non-compete agreements with certain healthcare employees. The legislation, Senate Bill 1318 (“SB 1318” codified in Tex. Bus. Com. Code §...more

Sheppard Mullin Richter & Hampton LLP

Minnesota May Be First to Require Social Media Warning Label

Minnesota has a new law that, beginning a year from now, will require that social media companies warn users of the potential negative mental health effects of social media use each time a user accesses a social media...more

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