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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.

Senators Introduce Better Food Disclosure Act

U.S. Sens. Roger Marshall (R-Kan.), Rick Scott (R-Fla.) and Katie Britt (R-Ala.) have introduced legislation they assert would improve U.S. Food and Drug Administration...

United States Healthcare

SH

Shook, Hardy & Bacon

CMS Releases CY 2026 Hospital OPPS And Ambulatory Surgical Center Final Rule

On Nov. 21, 2025, the Centers for Medicare & Medicaid Services (CMS or Agency) released the calendar year (CY) 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center...

United States Healthcare

HK

Holland & Knight

Medical/Commercial Activities And Interactions: Benchmarking And Compliance Insights

At the October 2025 Pharmaceutical and Medical Device Ethics and Compliance Congress, principals Jennifer A. Romanski and Michelle D. Axelrod participated in a session entitled...

United States Healthcare

PB

Porzio, Bromberg & Newman

Trump To Impose 100% Tariff On Some Imported Prescription Drugs

President Donald Trump recently posted on Truth Social that he intends to impose a 100% tariff on some imported prescription drugs, effective October 1, 2025.

United States Healthcare

HB

Hall Benefits Law

Increased Federal Enforcement Of Illicit Ends Products

Worldwide Healthcare

BI

Buchanan Ingersoll & Rooney PC

The Hidden Liability In Your EMR: How Documentation Errors Drive Medical Malpractice Claims

United States Healthcare

WE

Wilson Elser Moskowitz Edelman & Dicker LLP

FDA Outlines "Plausible Mechanism" Approval Pathway For Personalized Therapies, But Significant Questions Remain

United States Healthcare

RG

Ropes & Gray LLP

Quilting Circle: The Growing Patchwork Of State Food + Consumer Product Regulation

United States Healthcare

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Davis Wright Tremaine

Food Venture Financing News – Weekly Issue No. 262

United States Healthcare

DW

Davis Wright Tremaine

FDA Issues First Draft Guidance In The Countdown To QMSR

United States Healthcare

HP

Hyman, Phelps, & McNamara

DOJ Expands Health Care Fraud Strike Force To Massachusetts As Health Care Enforcement Remains An Administration Priority

United States Criminal

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Lowenstein Sandler

Operationalizing The Medical Frailty Exemption: A Step-by-Step Implementation Toolkit For States

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Bicameral, Bipartisan Bill Would Strengthen U.S. Biopharmaceutical Manufacturing

United States Healthcare

BC

Bergeson & Campbell

FDA Initiates Removal Of Warnings On Hormone Replacement Therapy

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

USCIS Announces Changes To The Naturalization Test

United States Immigration

Gs

Green and Spiegel

Green And Spiegel Partner Ksenia Maiorova Secures Major Win In NIL Visa Lawsuit

United States Immigration

Gs

Green and Spiegel

USPTO Proposes Dramatic Restrictions For Inter Partes Review Institution

United States IP

OB

Osha Bergman Watanabe & Burton LLP

One Size Doesn't Fit All: Customizing Dispute Resolution For Commercial Contracts

United States Litigation

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JAMS

From Conflict To Clarity: Why The ADR Experience Matters In Successful Resolution

United States Litigation

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JAMS

Preparing For HRSA's 340B Rebate Model Pilot Program And The Beacon Platform

On October 30, HRSA announced that it had selected eight drug manufacturers to participate in its 340B Rebate Model Pilot Program, spanning 10 drugs representing a range of widely used therapies.

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

Pharmacy Benefit Managers Ask Appeals Panel To Send Case Against FTC To Federal Court

These PBMs are attempting to stop the FTC's internal proceedings against them while the constitutional challenge plays out.

United States Healthcare

DM

Duane Morris LLP

FDA In Flux — November 2025 Newsletter

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

United States Healthcare

M

Mintz

Reforming GRAS: Digesting The Proposed "Better Food Disclosure Act" (S. 3122)

Senator Roger Marshall (R-KS) introduced much-anticipated legislation this month that seeks to reform the process by which "generally recognized as safe" (GRAS) substances are assessed by the U.S. Food and Drug Administration (FDA).

United States Healthcare

WR

Wiley Rein

FDA Leadership Outlines "Plausible Mechanism" Pathway For Bespoke Therapies

United States Healthcare

FH

Foley Hoag LLP

Regeneron Moves To Strike And Dismiss Amgen's Counterclaims In Aflibercept Litigation

United States IP

GP

Goodwin Procter LLP

IEEPA Reciprocal Tariff Product Exclusions Expanded To Food, Fertilizer

United States International

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Cassidy Levy Kent

Employers Grapple With GLP-1 Coverage For Weight Loss

United States Employment

OD

Ogletree, Deakins, Nash, Smoak & Stewart

An Overview Of The Over-the-Counter Monograph Drug User Fee Amendments (OMUFA): Policy Areas To Watch

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

Major Pasta Recall Illustrates Issues That Could Arise Under Food Contamination Insurance Policies

United States Insurance

CO

Cozen O'Connor

Vera Therapeutics Submits BLA To FDA For Atacicept Fusion Protein

United States Healthcare

GP

Goodwin Procter LLP

New OTC Drug And Sunscreen Provisions Passed In Congress

United States Healthcare

PC

Perkins Coie LLP

FDA's New "Plausible Mechanism Pathway" And Other Initiatives To Expedite Approval Of Drugs For Ultra-Rare Conditions

United States Healthcare

AP

Arnold & Porter

FDA Approves Shanghai Henlius's Interchangeable Pertuzumab Biosimilar

United States Healthcare

GP

Goodwin Procter LLP

Vera Therapeutics Submits BLA To FDA For Atacicept Fusion Protein

On November 7, Vera Therapeutics announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) through the Accelerated Approval Program for atacicept for the treatment...

United States Healthcare

GP

Goodwin Procter LLP

New OTC Drug And Sunscreen Provisions Passed In Congress

In the Continuing Resolution and Appropriations Package (H.R. 5371), enacted into law on November 12, 2025, Congress included several new provisions regarding over-the-counter (OTC) drug and sunscreen products.

United States Healthcare

PC

Perkins Coie LLP

FDA's New "Plausible Mechanism Pathway" And Other Initiatives To Expedite Approval Of Drugs For Ultra-Rare Conditions

Rare and ultra-rare disease product developers face numerous complexities, including in designing and executing clinical trials in very small patient populations, defining and validating endpoints, satisfying the statutory evidentiary standard for product approval, and attracting investment for products with uncertain trajectories.

United States Healthcare

AP

Arnold & Porter

FDA Approves Shanghai Henlius's Interchangeable Pertuzumab Biosimilar

On November 13, 2025, the FDA approved Shanghai Henlius Biologics Co. Ltd.'s POHERDY (pertuzumab-dpzb) as an interchangeable biosimilar to Genentech's PERJETA (pertuzumab).

United States Healthcare

GP

Goodwin Procter LLP

FDA Seeks Guidance From The Digital Health Advisory Committee On AI: Considerations For Innovators Of Digital Mental Health Medical Devices And Wellness Products

United States Healthcare

B

BakerHostetler

Microplastics Update: Regulatory And Litigation Developments In 2025

Microplastics pollution has emerged as a significant issue as the public learns more about the presence of microplastics in the environment and how they may enter the human body.

United States Environment

CM

Crowell & Moring LLP

Cigna's Rebate-Free Model: What It Really Means For Plan Sponsors, Pharmacies And The Industry

Cigna's announcement that it will shift to a "rebate-free" pharmacy benefit model has sent a jolt through an industry that has long depended on rebates as both a financial engine and a source of controversy.

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Pharmaceutical Policy In Motion: Updates On The Trump Administration's Drug Pricing Initiatives

Since May, the Trump administration has used tariffs and Most Favored Nation (MFN) drug pricing threats as a means to pressure pharmaceutical manufacturers to lower drug prices in the U.S.

United States Healthcare

M

Mintz

Finalized Changes To Medicare Payment Rules: Key Takeaways For Life Sciences Companies

The Centers for Medicare & Medicaid Services ("CMS") recently finalized a Medicare payment rule with significant implications for life sciences companies, particularly biotech...

United States Healthcare

RG

Ropes & Gray LLP

Federal Courts Quash Administrative Subpoenas And Review First Amendment Subpoena Challenge, Paving The Way For Future Investigatory Subpoena Contests

United States Government

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Barnes & Thornburg LLP

Trust A Farmer To "Do The Right Thing"!

United States Healthcare

MB

Michael Best

Benesch Healthcare+ Dialysis & Nephrology Digest No. 70

United States Healthcare

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Benesch Friedlander Coplan & Aronoff LLP

Testing One, Two, Three…

United States Healthcare

SJ

Steptoe LLP

Inside Litigation - Reshaping Product Liability Defense Strategies (Video)

United States Consumer

AP

Arnold & Porter

Cosmetics Industry Regulatory Challenges Accelerate

United States Energy

BB

Baker Botts LLP

California Enacts New Law Requiring California Licensure For Pharmacists-in-Charge Of Nonresident Pharmacies — Effective July 1, 2026

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

FDA Seeks To Accelerate Biosimilar Development By Easing Data Requirements

United States Healthcare

WR

Wiley Rein

CMS Releases CY 2026 Medicare Physician Fee Schedule Final Rule

United States Healthcare

HK

Holland & Knight

Administration Announces CMMI Model On Medicaid Drug Discounts, Strikes Deals On MFN Pricing For GLP-1s

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

M&A In GLP-1 Technology: Practical Recommendations And Best Practices

United States Healthcare

FL

Foley & Lardner

Patients Over Profit Act: A Federal Inflection Point On Insurer-Provider Integration And What Comes Next

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

The Patent Eligibility Restoration Act: Revisions To Section 101 Moving Closer To The Finish Line

United States IP

UT

Upadhye Tang

Ninth Circuit Upends USDA's Bioengineered Food Disclosure Requirements

United States Healthcare

WR

Wiley Rein

Don't Let The Stark Law Catch You Off Guard: Risk Remains Despite The Lull

United States Healthcare

PL

Polsinelli LLP

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Highlighted Content

The Nexus Of Trade And Food Security Amid Global Conflicts

United States International

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Braumiller Law Group, PLLC

Any Comments On FDA's New Proposed Rule On Prior Notice Regulations?

United States International

BG

Braumiller Law Group, PLLC

World Trade And Invasion, One Year Later – Are We On The Brink Of A New World Order?

United States International

BG

Braumiller Law Group, PLLC

Infringement Of Repurposed Drug Patents And Skinny Labelling – Where Does The Balance Lie In The United States Today?

United States Healthcare

D

Dehns

Infringement Of Repurposed Drug Patents And Skinny Labelling – Where Does The Balance Lie In Europe Today?

United States Healthcare

D

Dehns

Latest Videos

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Navigating Food And Dietary Supplements Labeling Litigation & Regulatory Hurdles In 2025 And Beyond (Video)

SM

Sheppard Mullin Richter & Hampton

The Exploration Crisis: Why Oil & Gas Companies Are Finding Less While Demand Keeps Growing (Video)

AM

Alvarez & Marsal

Non-binding Guidance: The Administration's Focus On Direct-to-Consumer Prescription Drug Advertising (Podcast)

RG

Ropes & Gray LLP

Live From Workplace Horizons 2025: What's Hot In ERISA — Forfeiture And Tobacco Surcharge Class Actions (Video)

JL

Jackson Lewis P.C.

Concerns For Employers Surrounding Employee Drug And Alcohol Testing Policies (Video)

FS

Foster Swift Collins & Smith

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