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Holland & Knight LLP

FDA Announces "National Priority Voucher" Program to Accelerate Reviews of New Drugs

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The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced on June 17, 2025, the creation of a new initiative called the "Commissioner's National Priority Voucher" (CNPV)...more

Foley Hoag LLP

CMS Rescinds Post-Dobbs EMTALA Guidance, Raising New Questions for Emergency Departments

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I. Key Takeaways - Federal enforcement under the Emergency Medical Treatment and Labor Act (EMTALA) may be changing after the Centers for Medicare & Medicaid Services (CMS) rescinded guidance issued under the Biden...more

Sheppard Mullin Richter & Hampton LLP

What to Watch: Potential Increase in Enforcement of “RUO” Diagnostics

Last spring, we wrote about a warning letter the United States Food & Drug Administration (“FDA” or the “Agency”) issued to Agena Bioscience Inc. (the “Agena Warning Letter”) for allegedly promoting its diagnostic product...more

Jenner & Block

Inclusion of Microplastics in the Sixth Unregulated Contaminant Monitoring Rule?

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According to a Law360 article, U.S. EPA said in a statement to Law360 that it’s reviewing a November 2024 petition from 175 environmental groups to include microplastics in the Sixth Unregulated Contaminant Monitoring Rule...more

Bass, Berry & Sims PLC

Court Vacates HIPAA 2024 Final Rule Related to Reproductive Health Care Privacy

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On June 18, 2025, the U.S. District Court for the Northern District of Texas issued an opinion that vacates the 2024 final rule that enhanced privacy protections for protected health information (PHI) related to reproductive...more

Sheppard Mullin Richter & Hampton LLP

FDA Ratchets Enforcement on Social Media Promotion in New Warning Letter

The U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) recently posted a warning letter (the “Letter”, issued on May 29, 2025, to Sprout Pharmaceuticals, Inc. (“Sprout”) and its CEO,...more

Wiley Rein LLP

Federal Judge Blocks NIH Grant Cuts, Rejecting DOJ’s Claims of Unlawful Discrimination

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WHAT: A Massachusetts federal judge blocked the National Institutes of Health (NIH) from cutting hundreds of programs that provide grants to universities, hospitals, and other organizations. The judge found that NIH offered...more

Smart & Biggar

Health Canada consultation on revised biosimilar guidance: no requirement for comparative clinical efficacy and safety trials

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On June 10, 2025, Health Canada launched a consultation on its Draft Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs which includes numerous proposed revisions to the current guidance...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces Commissioner’s National Priority Voucher Program to Accelerate Drug Application Review Process and Support National...

On June 17, 2025, the U.S. Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a new program that aims to speed up drug application review for companies aligned with U.S....more

Bergeson & Campbell, P.C.

USDA TO THE RESCUE! First, Immigration Policies — Will MAHA be Next?

The U.S. Department of Agriculture (USDA) has been around for more than 150 years, stressing the importance of American agriculture to a bountiful food production system since Abraham Lincoln first signed it into being in...more

McAfee & Taft

Employer health plan surcharges pose litigation risks

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Many employers implement wellness programs into their employee health plan offering. Wellness programs have varying designs but commonly offer premium discounts to participants who are tobacco-free or achieve certain...more

Seyfarth Shaw LLP

Lone Star Limitations – Texas Further Narrows the Use of Non-Competes with Medical Professionals

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Texas imposes new limits on non-compete agreements with licensed physicians and health care professionals that takes effect September 1, 2025....more

Allen Matkins

Air District Asbestos Rule Will Affect Demolition Activities for Facilities Damaged by the Los Angeles Wildfires

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Owners and operators of facilities damaged or destroyed by the recent Los Angeles-area wildfires should be aware of the risks posed by toxic contaminant releases during cleanup and, in particular, the regulatory requirements...more

Hogan Lovells

MDCG published new guidance on the interplay between the MDR & IVDR and the AI Act

Hogan Lovells on

On 19 June 2025, the Medical Device Coordination Group (“MDCG”) published new guidance on the interplay between the MDR & IVDR and the AI Act (MDCG 2025-6). The document provides a first set of answers to the most frequently...more

Hanson Bridgett

CMS Announces Care Compare Changes That Could Lead to Major Five-Star Impacts for Certain SNFs

Hanson Bridgett on

On June 18, Centers for Medicare and Medicaid Services published new guidance announcing a major change to the way Care Compare will display survey information and the methodology for calculating the health inspection score...more

Morgan Lewis

On the Basis of Sex: HHS Rescinds Prior Section 1557 Guidance Interpreting Sex-Based Discrimination

Morgan Lewis on

The US Department of Health and Human Services (HHS) has rescinded several pieces of informal guidance, including its 2021 interpretation of Section 1557 of the Affordable Care Act (Section 1557), in response to executive...more

Venable LLP

Life in the Fast Lane! FDA Announces the Commissioner's National Priority Voucher Program

Venable LLP on

On June 17, the Food and Drug Administration announced the establishment of the Commissioner's National Priority Voucher (CNPV) program. Although initial details are sparse, the CNPV promises fast action, allowing drug...more

Dorsey & Whitney LLP

HIPAA’s 2024 Reproductive Health Rule is Vacated Nationwide - One Year After Going Into Effect

Dorsey & Whitney LLP on

On June 18, 2025, a Texas court issued a ruling that vacated, on a nationwide basis, the HIPAA Privacy Rule to Support Reproductive Health Care Privacy (the “Reproductive Health Rule”), just one year after the rule went into...more

Hendershot Cowart P.C.

GLP-1 Shortage Ended: Can You Still Legally Prescribe or Compound Semaglutide and Tirzepatide?

Hendershot Cowart P.C. on

For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more

Pullman & Comley - Labor, Employment and...

Federal Court Decision Reshapes ACA Enforcement by HHS and IRS

The recent federal district court decision in Faulk Company, Inc. v. Xavier Becerra, et al., No. 24-cv-00609-P (N.D. Tex. 2025) significantly alters the primary mechanism used by the U.S. Department of Health and Human...more

Proskauer - California Employment Law

Managing the “Infinite Workday”:  Employer Responsibilities in a 24/7 Work Culture

In today’s always-on world, the “infinite workday” has quietly taken over—creeping into dinners, weekends, and even that quaint concept known as a “vacation.” With smartphones in every pocket and teams spread across multiple...more

Brownstein Hyatt Farber Schreck

Key Differences in Provisions Between Draft Senate and House-Passed Reconciliation Bill

Over the last week, the Senate Finance Committee and Senate Agriculture Committee released their portions of reconciliation text, which includes most of the Medicaid and food insecurity provisions. The Senate committees will...more

Arnall Golden Gregory LLP

Not a Second Time: FDA’s Office of Prescription Drug Promotion Issues a Warning Letter to a Company for Unlawful Promotion

The authors were thinking of the Beatles’ 1963 song, “Not a Second Time,” when we read the latest Warning Letter from the Food and Drug Administration’s Office of Prescription Drug Promotion. The company received a Warning...more

Hall Benefits Law

PBM Contracts Could Expose Plan Sponsors to Fiduciary Liability

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A plan sponsor’s fiduciary duty to be transparent in Pharmacy Benefit Manager contracts safeguards plan participants’ interests and mitigates the risk of litigation, regulatory penalties, and reputational harm, say Hall...more

Epstein Becker & Green

DOJ Civil Division Announces 2025 Priorities: Promises “Aggressive” False Claims Act Enforcement of Civil Rights Violations and...

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On June 11, 2025, Assistant Attorney General Brett A. Shumate issued an internal memorandum (the “Shumate memo”) to all Civil Division employees of the U.S. Department of Justice (“DOJ”), describing the Division’s enforcement...more

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