United States: Food and Drugs Law

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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.

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

At the Federal Bar Association's (FBA's) 2026 Qui Tam Conference, Brenna Jenny, deputy assistant attorney general for the Commercial Litigation Branch of the Department of Justice (DOJ) Civil Division...

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HHS Kicks Off Rare Disease Week With FDA Release Of Draft Guidance On Plausible Mechanism Framework For Individualized Therapies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

FDA In Flux — February 2026 Newsletter

United States Healthcare

M

Mintz

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

United States Litigation

BT

Barnes & Thornburg LLP

New Year's Resolutions For Mediators (That Actually Change Outcomes)

United States Litigation

J

JAMS

401(k) And IRA Contribution Limits For 2026: Retirement Savings, Adjustments For Inflation, And SECURE 2.0 Changes American Taxpayers Must Know About

United States Tax

RS

Rotfleisch & Samulovitch P.C.

Congress Proposes Major Overhaul Of WARN: What Employers Need To Know About The Fair Warning Act

United States Employment

PR

Proskauer Rose LLP

Signed, Sealed, But Not Delivered? Don't Wonder About Taxes Under New Postal Service Rules

United States Tax

N

Nossaman LLP

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

Earlier today, the U.S. Supreme Court ("Court") determined that the International Emergency Economic Powers Act ("IEEPA")...

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

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

United States Healthcare

B

Benesch Friedlander Coplan & Aronoff 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

San Francisco's City Attorney has sued 11 major food companies, alleging they engineered ultra-processed foods to be addictive, concealed health risks, and targeted children and minority communities...

United States Healthcare

B

Benesch Friedlander Coplan & Aronoff LLP

Authenticity in Alcohol Labeling: What's Brewing?

United States Healthcare

HK

Holland & Knight

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?

Orleans Parish has opened the annual Alcoholic Beverage Outlet (ABO) renewal season, and operators should move promptly to avoid late penalties and business disruptions.

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

A Settlement, Not A Sigh Of Relief: What The FTC's Express Scripts Deal Signals For Enforcement Risk

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

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

Inside Litigation - Reshaping Product Liability Defense Strategies (Video)

AP

Arnold & Porter

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.

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