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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.

FDA Continues To Ease Regulatory Hurdles For Wearable Health Products

The US Food and Drug Administration (FDA) recently updated two guidance documents applicable to wearable devices and guidance for clinical decision support (CDS) tools...

United States Healthcare

SP

Squire Patton Boggs LLP

Review Of EPO Antibody Decisions In 2025

Welcome to the latest edition of J A Kemp's annual review of EPO Board of Appeal decisions concerning antibody inventions. In this update, we examine decisions issued between 31 January 2025 and 31 December 2025.

United States IP

JA

J A Kemp LLP

Legal Uncertainty Clouds Direct-To-Consumer Drug Program After OIG Advisory And Senate Scrutiny

The advisory addresses TrumpRX, a DTC prescription drug platform designed to facilitate patient access to certain medications outside of the traditional pharmacy benefit and reimbursement framework.

United States Criminal

WR

Wiley Rein

340B Rebate Model Pilot Program Effectively Ends Preserving Upfront Discounts, For Now

In American Hospital Association v. Kennedy, the U.S. Court of Appeals for the First Circuit denied the government's motion to stay the U.S. District Court for the District of Maine's nationwide preliminary injunction...

United States Healthcare

BT

Barnes & Thornburg LLP

DOJ Signals Continued Aggressive False Claims Act Enforcement

United States Criminal

SA

Skadden Arps Slate Meagher & Flom

HHS Kicks Off Rare Disease Week With FDA Release Of Draft Guidance On Plausible Mechanism Framework For Individualized Therapies

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

FDA's Makary Declares Upcoming Crackdown On GLP-1 Claims, Importation

United States Healthcare

SR

McDermott Will & Schulte

Bridging AI And Clinical Reality: Lessons From The Mayo Clinic Platform In Precision Medicine

United States Technology

FL

Foley & Lardner

Colorado SB 26-094: A Potential Game-Changer For Craft Distillers And Colorado's Alternating Proprietor Framework

United States Healthcare

CH

Clark Hill

'Same Active Ingredient' In Compounded Drug Advertising: FDA's New Enforcement Approach

United States Healthcare

SA

Skadden Arps Slate Meagher & Flom

Industry Victory: Texas Food Additive Labeling Law Put On Ice

United States Healthcare

FB

FBT Gibbons

FDA Issues Draft Guidance On Using The "Plausible Mechanism" Framework To Develop Individualized Therapies For Rare Genetic Diseases

United States Healthcare

FL

Foley & Lardner

Tax Law Increasingly Subject To Administrative And Constitutional Law

United States Tax

SA

Skadden Arps Slate Meagher & Flom

The Long Tail Of The Opioid Crisis: How AGs Continue To Pursue Manufacturers, Distributors, Pharmacies

United States Healthcare

B

Benesch Friedlander Coplan & Aronoff LLP

SECURE 2.0: Key Provisions And Tax Planning Implications For American Retirees

United States Tax

RS

Rotfleisch & Samulovitch P.C.

Seventh Circuit Roundup: What Recent Decisions Reveal About Pleading, Intent, And Immunity (Podcast)

United States Litigation

BT

Barnes & Thornburg LLP

Ohio's New E-Verify Workforce Integrity Act: What Construction Employers Need To Know

United States Immigration

Gs

Green and Spiegel

Debt's Grip: What Consumer Bankruptcy Reveals About Financial Risk In America (Podcast)

United States Insolvency

BS

Ballard Spahr LLP

What Foundations And Other Nonprofits Need To Know About The Foreign Agents Registration Act

United States Government

W

WilmerHale

FDA In Flux — February 2026 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

FDA Approves Accord's FILKRI (Filgrastim-laha), A Biosimilar To NEUPOGEN

On February 17, 2026, the U.S. Food and Drug Administration (FDA) approved FILKRI (filgrastim-laha)...

United States Healthcare

GP

Goodwin Procter LLP

SCOTUS Disarms President Trump In Trade War, Scrapping Tariff Authority

Today, the Supreme Court dealt a heavy blow to President Trump's trade agenda, concluding that the International Emergency Economic Powers Act...

Worldwide International

BS

Ballard Spahr LLP

New Oral Polio Vaccine Type 2 (NOPV2) Prequalified By WHO

On February 10, 2026, the World Health Organization ("WHO") prequalified a new novel oral polio vaccine type 2 ("nOPV2") product.

Worldwide Healthcare

GP

Goodwin Procter LLP

Supreme Court Strikes Down IEEPA Tariffs; Refund Process To Be Determined

United States International

GP

Goodwin Procter LLP

HRSA Requests Comments On Future 340B Rebate Model Development

United States Healthcare

SR

McDermott Will & Schulte

Formycon And Lotus Expand Collaboration In Asia-Pacific Region To Pembrolizumab Biosimilar

United States Healthcare

GP

Goodwin Procter LLP

Celebrating Black History Month -- Dr. Charles Drew, The Doctor Who Revolutionized Blood Storage

United States Employment

CL

Cowan Liebowitz & Latman PC

Trump Administration Pursues MFN Pricing For Prescription Drugs

United States Healthcare

CM

Crowell & Moring LLP

Senate HELP Committee Releases FDA Modernization Report: "Patients And Families First: Building The FDA Of The Future"

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Iowa Asks Eighth Circuit To Unblock Key Pharmacy Benefit Manager Reform Law Provisions

United States Healthcare

DM

Duane Morris LLP

Florida Federal Court Rules FDA Denial Of Citizen Petition Is Final Agency Action

United States Healthcare

DM

Duane Morris LLP

Virginia Sues PBMs And Insulin Manufacturers Over Inflated Pricing Scheme

United States Consumer

HB

Hall Benefits Law

Consolidated Appropriations Act Of 2026 Requires Greater Transparency By Pharmacy Benefit Managers

United States Healthcare

GB

Genova Burns

Iowa Asks Eighth Circuit To Unblock Key Pharmacy Benefit Manager Reform Law Provisions

On February 13, 2026, the state of Iowa filed an appellate brief with the United States Court of Appeals for the Eighth Circuit...

United States Healthcare

DM

Duane Morris LLP

Florida Federal Court Rules FDA Denial Of Citizen Petition Is Final Agency Action

On January 29, 2026, the District Court for the Southern District of Florida sided with plaintiff Hybrid Pharma LLC...

United States Healthcare

DM

Duane Morris LLP

Virginia Sues PBMs And Insulin Manufacturers Over Inflated Pricing Scheme

The Commonwealth of Virginia has filed suit against various pharmacy benefit managers (PBMs) and insulin manufacturers for allegedly violating the Virginia Consumer Protection Act. According to the lawsuit, the defendants...

United States Consumer

HB

Hall Benefits Law

Consolidated Appropriations Act Of 2026 Requires Greater Transparency By Pharmacy Benefit Managers

On February 3, 2026, Congress passed and President Trump signed into law the Consolidated Appropriations Act of 2026 (CAA).

United States Healthcare

GB

Genova Burns

California Food Fight: The SF City Attorney's Snack Attack

United States Healthcare

B

Benesch Friedlander Coplan & Aronoff LLP

Cannabis In 2026 – Part III: What Schedule III Could Mean For State-Legal Cannabis Operations: Real Upside, Persistent Friction

Federal cannabis policy is evolving quickly, and key details will turn on how the Department of Justice and the U.S. Drug Enforcement Agency finalize any Schedule III action...

United States Cannabis

SM

Sheppard, Mullin, Richter & Hampton LLP

FDA To Allow New 'No Artificial Colors' Labeling Claims

On February 5, the US Food and Drug Administration (FDA) announced it will now allow food companies to use "no artificial colors" claims when foods do not contain any food, drug, and cosmetic (FD&C)-certified synthetic...

United States Healthcare

AF

ArentFox Schiff

Four Takeaways From The Business Of Healthcare Conference At The University Of Miami Herbert Business School

The University of Miami Herbert Business School's Business of Healthcare conference on February 6, 2026...

United States Healthcare

SM

Sheppard, Mullin, Richter & Hampton LLP

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 125

This update (No. 125 | 2 January 2026) covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia's war against Ukraine, health threats, and cyber threats.

United States Strategy

JD

Jones Day

New Orleans ABO Renewal Season: Are You Ready?

United States Healthcare

Aa

Adams and Reese

Let's Go Do This: Texas Cuts Red Tape on ‘Cottage Food Industry'

United States Healthcare

DJ

Decker Jones

Color Me Compliant: FDA's New "No Artificial Colors" Enforcement Approach

United States Healthcare

SM

Sheppard, Mullin, Richter & Hampton LLP

The Ghost In The Machine (Readable Files): Proposed Transparency In Coverage Amendments Attempt To Shed Additional Light On Health Plan Data

United States Employment

GL

Groom Law Group

New FDA Drug Reforms: Congress Extends Voucher Incentive, Clarifies Orphan Exclusivity And Provides Greater Transparency For Q1/Q2 Generic Approvals

United States Healthcare

PL

Polsinelli LLP

Leaders In Law: Life Sciences And Technology Transactions With Jekkie Kim (Podcast)

United States Healthcare

W

WilmerHale

New Transparency Requirements For Pharmacy Benefit Managers: What Group Health Plan Sponsors Need To Know

United States Employment

WS

Winston & Strawn LLP

Food Update | GRAS‑ping The Moment: FDA GRAS Reform Steps Into The Spotlight

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

Telehealth's Weight-Loss Boom And The Corporate Practice Of Medicine

United States Healthcare

DW

Dickinson Wright PLLC

Government Issues New Model HIPAA Notice

United States Healthcare

BS

Ballard Spahr LLP

High-Level Comparison Of The Department Of Labor's PBM Fee Disclosure Proposed Rule And The PBM Disclosure And Rebate Provisions In CAA, 2026

United States Employment

GL

Groom Law Group

Congress Rallies To Extend Rare Pediatric Disease Priority Review Voucher Program

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

Massachusetts Introduces Legislation To Regulate Pharmacy Benefit Managers

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

FDA Announces New Enforcement Policy On "No Artificial Colors" Food Labeling

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Time Flies! Cosmetic Manufacturing Facilities Are Due For FDA Registration Renewal

United States Healthcare

WR

Wiley Rein

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Highlighted Content

The Nexus Of Trade And Food Security Amid Global Conflicts

United States International

BG

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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Leaders In Law: Life Sciences And Technology Transactions With Jekkie Kim (Podcast)

W

WilmerHale

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

Critical Medical Device Series: Part VI Navigating Innovation: The FDA's Role In Regulating Medical Technology (Video)

AP

Arnold & Porter

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

JL

Jackson Lewis P.C.

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