Worldwide: Food and Drugs Law

Subscribe

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.

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

The GLP-1 revolution has rewritten the playbook for metabolic disease, and it's also reshaping dealmaking

United States Healthcare

FL

Foley & Lardner

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

For years, the conversation around health insurer consolidation and vertical integration has simmered through antitrust inquiries, oversight hearings, and policy papers.

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

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

PERA is hardly new; substantially similar laws were proposed in each year since 2022. But momentum may be growing

United States IP

UT

Upadhye Tang

Ninth Circuit Upends USDA's Bioengineered Food Disclosure Requirements

In Natural Grocers v. Rollins, the U.S. Court of Appeals for the Ninth Circuit significantly upended certain parts of the U.S. Department of Agriculture's (USDA) National Bioengineered Food Disclosure Standard (BE Rule).

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

FDA Accelerates Again: The Second CNPV Cohort

United States Healthcare

HP

Hyman, Phelps, & McNamara

CMS Announces GENEROUS Model For Most Favored Nation Pricing In Medicaid

United States Healthcare

HP

Hyman, Phelps, & McNamara

Ninth Circuit Issues Significant Ruling On Bioengineered Food Disclosure Standard

United States Healthcare

PC

Perkins Coie LLP

FDA Considers Drug Pricing: Leadership Cites Consumer Cost As A Driver For Changes To Biosimilar Recommendations

United States Healthcare

FL

Foley & Lardner

When EPA Steps Back: How States Are Leading Enforcement Amid Deregulation – Prepare Your Company

United States Environment

SJ

Steptoe LLP

Amgen Files BPCIA Complaints Against Dr. Reddy's/Alvotech And Amneal Regarding Denosumab Biosimilars

United States Healthcare

GP

Goodwin Procter LLP

CMS Finalizes Key Requirements For Bona Fide Service Fees In CY 2026 Physician Fee Schedule Rule

United States Healthcare

M

Mintz

Ninth Circuit Sends USDA's Agricultural Marketing Service ("AMS") Back To Drawing Board On Some Aspects Of The BE Labeling Rule

United States Healthcare

HP

Hyman, Phelps, & McNamara

CMS Implements Major Drug Pricing Changes In CY 2026 Physician Fee Schedule Final Rule

United States Healthcare

HP

Hyman, Phelps, & McNamara

Why Direct Student-Athlete Payments Create An Immigration Crisis For Universities

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

The Changes To The English Arbitration Regime: What Parties To International Construction Disputes Need To Know

United States Litigation

J

JAMS

Control, Creativity, Closure: The Mediation Advantage

United States Litigation

J

JAMS

What Honeybees Have Taught Me About Dispute Resolution

United States Litigation

J

JAMS

Executive Branch Focus On Federally Funded Inventions

In recent months the executive branch has indicated a willingness to assert control over intellectual property funded by federal research dollars in novel ways. This could potentially include leveraging its march-in rights under the Bayh-Dole Act.

United States Healthcare

CM

Crowell & Moring LLP

California Continues To Lead The Way In "Healthy" Food Regulation

On October 8, 2025, California Governor Gavin Newsom signed into law another first-of-its-kind, California state-law attempt at promoting healthier nutrition.

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

Food Venture Financing News – Weekly Issue No. 260

The EVERY Company, known for its animal-free egg whites and egg white proteins, announced that it raised $55 million in its Series D financing round.

United States Healthcare

DW

Davis Wright Tremaine

CMS Finalizes Changes To Bona Fide Service Fee Requirements, Alongside Other Adjustments To Medicare Part B Drug Reimbursement Methodology

On October 31, 2025, the Centers for Medicare & Medicaid Services (CMS) released its Final Rule for the Calendar Year (CY) 2026 Physician Fee Schedule (PFS), detailing significant updates to Medicare Part B payment policies.

United States Healthcare

GP

Goodwin Procter LLP

The Regulatory Compliance Defense For "Improper" Orange Book Listings

United States IP

W

WilmerHale

Kratom & 7-OH Update

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Filling The Gaps And Navigating Fine Lines: Regulatory Compliance Framework And Considerations For California Medical Spas

United States Healthcare

M

Mintz

Rare Disease Focus: FDA's Trio Of Cell And Gene Therapy Draft Guidances Highlight Expedited Programs, Innovative Trial Designs, And Postapproval Evidence Generation

United States Healthcare

RG

Ropes & Gray LLP

Hikma Launches Ustekinumab Biosimilar STARJEMZA

United States Healthcare

GP

Goodwin Procter LLP

PBM Policy And Legislative Update — Summer / Fall 2025 (Podcast)

United States Healthcare

M

Mintz

What's Changing At The US Federal Level For Food Contact Materials?

United States Healthcare

BD

Beveridge & Diamond

Sip, Sip, Hooray? An Analysis Of Florida's SIP Proposal To Curb High Pharmaceutical Prices

United States Healthcare

PD

Phelps Dunbar LLP

CMS Launches Mandatory Two-Sided Risk Model For Specialists Treating Heart Failure And Low Back Pain

United States Healthcare

BB

Bass, Berry & Sims

Takeda And Innovent Biologics Enter Collaboration Agreement On IBI343 And IBI363 Cancer Drugs

Worldwide Healthcare

GP

Goodwin Procter LLP

What's Changing At The US Federal Level For Food Contact Materials?

A significant recalibration of how substances that come into contact with food are reviewed, authorised and monitored is on the cards...

United States Healthcare

BD

Beveridge & Diamond

Sip, Sip, Hooray? An Analysis Of Florida's SIP Proposal To Curb High Pharmaceutical Prices

The United States faces significantly higher pharmaceutical prices compared to other developed nations, with brand-name drugs averaging more than three times the costs found abroad.

United States Healthcare

PD

Phelps Dunbar LLP

CMS Launches Mandatory Two-Sided Risk Model For Specialists Treating Heart Failure And Low Back Pain

On October 31, the Centers for Medicare & Medicaid Services (CMS) finalized the Ambulatory Specialty Model (ASM)...

United States Healthcare

BB

Bass, Berry & Sims

Takeda And Innovent Biologics Enter Collaboration Agreement On IBI343 And IBI363 Cancer Drugs

Last week, Takeda announced that it has entered into a worldwide license and collaboration agreement (outside of Greater China) with Innovent Biologics for the development, manufacture, and commercialization...

Worldwide Healthcare

GP

Goodwin Procter LLP

Spotlight On Upcoming Oral Arguments – November 2025

United States IP

FH

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

The Tests They Are A-Changing: FDA Takes Action On Biosimilars

Biosimilars, costing about 50% of their reference products, have generated $56 billion in healthcare savings since 2015, with $20 billion saved in 2024 alone.

United States Healthcare

HP

Hyman, Phelps, & McNamara

Holland & Knight Health Dose: November 4, 2025

This week, the government shutdown entered its fifth week and, on Nov. 4, 2025, became the longest in history, beating a 34-day-plus record set during President Donald Trump's first term.

United States Healthcare

HK

Holland & Knight

European Bioeconomy Alliance Report Confirms Benefits Of Using First-Generation Biomass For Food, Fuels, And Chemicals In Europe

The European Bioeconomy Alliance (EUBA) announced on October 1, 2025, the release of an expert paper from the nova-Institute...

European Union Healthcare

BC

Bergeson & Campbell

FDA Proposes To Eliminate Comparative Clinical Efficiency Studies For Biosimilars

In a new draft guidance issued on October 29, 2025, the U.S. Food and Drug Administration (FDA) announced that it will drastically pare back the requirement of data from comparative clinical efficiency studies (CES)...

United States Healthcare

AP

Arnold & Porter

California's New Allergen-Disclosure Law: A Sign Of Things To Come?

United States Healthcare

HP

Hyman, Phelps, & McNamara

Onshoring Drug Manufacturing: Insights From FDA's PreCheck Initiative And Public Meeting

United States Healthcare

HP

Hyman, Phelps, & McNamara

You've Got Mail, And Twice The Time To Respond! Two Device Companies Find Themselves With 30 Business Days To Respond To FDA's Warning Letters

United States Healthcare

HP

Hyman, Phelps, & McNamara

Bring Out Your Meds! Bring Out Your Meds!

United States Healthcare

HP

Hyman, Phelps, & McNamara

Where Have All The Good Guidance Gone?

United States Healthcare

HP

Hyman, Phelps, & McNamara

Strengthening Postapproval Monitoring: FDA's Draft Guidance On Cell & Gene Therapy Products

United States Healthcare

HP

Hyman, Phelps, & McNamara

Real Food, Healthy Kids – And It's Not An Act

United States Healthcare

HP

Hyman, Phelps, & McNamara

RRA, RIE And MRA: FDA's Evolving Inspection Toolkit Still Has Boundaries

United States Healthcare

HP

Hyman, Phelps, & McNamara

FDA Proposes To Remove Comparative Efficacy Studies To Accelerate Biosimilar Development

United States Healthcare

JD

Jones Day

The Profit Crunch: How US Policy Could Reshape Global Pharma Research And Development (R&D)

Worldwide Healthcare

AM

Alvarez & Marsal

Health Headlines: October 2025

United States Healthcare

GP

Goodwin Procter LLP

Current Opportunities And Challenges In RWE And Its Future With AI

United States Healthcare

HP

Hyman, Phelps, & McNamara

Senate Passes Revised Version Of The BIOSECURE Act

United States Healthcare

HP

Hyman, Phelps, & McNamara

RWE And AI: Hand In Hand In The Future Of Regulatory Decision Making

United States Healthcare

HP

Hyman, Phelps, & McNamara

Inaugural Class Of Commissioner's National Priority Voucher Recipients Announced

United States Healthcare

HP

Hyman, Phelps, & McNamara

See more

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

See more

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

Food And Consumer Product Litigation And Regulatory Update: Webinar Replay (Video)

ML

McGuireWoods LLP

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More