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.

What To Watch: WHOOP Warning Letter

On July 14, the U.S. Food and Drug Administration ("FDA" or the "Agency") issued a warning letter (the "Warning Letter") to WHOOP, Inc. ("WHOOP"), rejecting WHOOP's claim that its wearable...

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

Optional Refrigeration Freezes Induced Patent Infringement Claim

In Metacel Pharmaceuticals LLC v. Rubicon Research Private Ltd., the Court of Appeals for the Federal Circuit (CAFC) held that the optional product storage temperatures stated in Rubicon's...

United States IP

KG

K&L Gates LLP

FDA Announces Availability Of ICH Draft Guidance On Inclusion Of Pregnant And Breastfeeding Women In Clinical Trials

On Monday, July 21, 2025, the Food and Drug Administration (FDA) issued draft guidance entitled "E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials...

United States Healthcare

CM

Crowell & Moring LLP

Big Surprises Unveiled In CMS's Proposed 2026 Medicare Physician Fee Schedule: Major Implications For FMV And Bona Fide Service Fee Assessments

On July 16, 2025, the Centers for Medicare & Medicaid Services (CMS) proposed significant changes to the definition and treatment of bona fide service fees (BFSFs) within its 2026 Medicare Physician Fee Schedule Proposed...

United States Healthcare

AC

Ankura Consulting Group LLC

Move Fast: FDA Is Accepting Submissions For The Pilot Program Class For FDA Commissioner's National Priority Voucher Program

United States Healthcare

GP

Goodwin Procter LLP

Major Update On GLP-1 Litigation Involving Compounding Pharmacies

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Creatine Is The Next Big Thing In Food And Beverage. Here's Why.

United States Healthcare

MB

Michael Best

Five Key Ways The Budget Reconciliation Bill Could Impact Life Sciences—and How To Prepare

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Advancing Sustainable Agriculture Through Plant Biotechnology

United States Healthcare

JA

J A Kemp LLP

Louisiana And Texas Enact New Laws Regarding Food Ingredient Disclosures And School Nutrition

United States Healthcare

PC

Perkins Coie LLP

340B Rebate Pilot Program Proposed By HRSA

United States Healthcare

GP

Goodwin Procter LLP

In Neurelis v. Brenner, The FDA's "Indication-Specific" View Of Orphan Exclusivity Is (Again) Struck Down

United States Healthcare

MB

Mayer Brown

How Do You Define Ultra-Processed Food? FDA And USDA Issue RFI To Establish Definition

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

USDA Ramps Up Food Safety Strategy

United States Healthcare

KM

Katten Muchin Rosenman LLP

Analysis Of The 2025 Federal Tax Changes Under The "One Big Beautiful Bill" Legislation

B

BakerHostetler

Blockchain 2025 - Trends And Developments

United States Technology

WS

Winston & Strawn LLP

Is The Economy Shifting? Ankura's July 2025 U.S. Economic Tracker Reveals Key Trends

United States Strategy

AC

Ankura Consulting Group LLC

Artificial Intelligence 2025 - Trends And Developments

United States Technology

SJ

Steptoe LLP

The Art Of The (UK) Deal

United States International

BG

Braumiller Law Group, PLLC

Federal Judge Saddles CVS Caremark With $95 Million Judgment

A federal judge in Pennsylvania recently issued a ruling finding that CVS Caremark Corp., a pharmacy benefits manager (PBM), owed the federal government $95 million...

United States Healthcare

HB

Hall Benefits Law

HHS And DOJ Revitalize False Claims Act Working Group

The U.S. Department of Health and Human Services (HHS) and U.S. Department of Justice (DOJ) on July 2, 2025, announced their intent to strengthen the DOJ-HHS False Claims Act Working Group.

United States Healthcare

HK

Holland & Knight

Entresto Trade Dress Dispute: No Injunctive Relief For Novartis

On July 15, 2025, Judge Evelyn Padin of the District of New Jersey denied Novartis's motion for preliminary injunction, which would have blocked MSN Laboratories Pvt. Ltd. from selling a generic version of Novartis's Entresto based on alleged trade dress infringement.

United States IP

AV

Axinn Veltrop & Harkrider

Health Headlines: July 2025

The challenged Final Rule was issued on June 20, 2025, and is set to go into effect on August 25, 2025. The Final Rule would make numerous changes to the operations of the ACA marketplace.

United States Healthcare

GP

Goodwin Procter LLP

States Challenge New Federal Restrictions On Benefits For Noncitizens, Suing HHS And Other Agencies

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

CMS Releases Guidance On Interpretation Of Medicaid Covered Outpatient Drug

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Two's Company, Three's A Crowd: District Court Dismisses Complaint Because Of Group Pleading

United States Criminal

AP

Arnold & Porter

Iowa Amends Drug Testing Statute, Relieves Some Employer Burdens

United States Healthcare

JL

Jackson Lewis P.C.

Texas And Louisiana Enact 'MAHA'-Inspired Food Additive Legislation

United States Healthcare

GT

Greenberg Traurig, LLP

Clear The Air: FDA Cracks Down On Illegal Vapes Entering The U.S.

Worldwide Healthcare

BI

Buchanan Ingersoll & Rooney PC

Pharma Company Challenges The U.S. False Claims Act: What's At Stake For Whistleblowers And Government Enforcement?

United States Healthcare

AO

A&O Shearman

Are You "Cali-sober"?

United States Healthcare

MB

Michael Best

CMS Proposes New Standards For Bona Fide Service Fees In Average Sales Price Calculations: What Plans, PBMs, And Other Recipients Of BFSFs Need To Know

United States Healthcare

M

Mintz

Holland & Knight Health Dose: July 29, 2025

United States Healthcare

HK

Holland & Knight

Pharma Company Challenges The U.S. False Claims Act: What's At Stake For Whistleblowers And Government Enforcement?

A pharmaceutical company is currently appealing a record USD1.6 billion judgment in the US, arguing that a key part of the U.S. False Claims Act (FCA) is unconstitutional.

United States Healthcare

AO

A&O Shearman

Are You "Cali-sober"?

Just over a year ago, my firm merged with a firm in Los Angeles. Since then, I've had a chance to meet a number of our new lawyers and to a person, they have been fantastic.

United States Healthcare

MB

Michael Best

CMS Proposes New Standards For Bona Fide Service Fees In Average Sales Price Calculations: What Plans, PBMs, And Other Recipients Of BFSFs Need To Know

The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs)...

United States Healthcare

M

Mintz

Holland & Knight Health Dose: July 29, 2025

This week, the U.S. House of Representatives will be out of session, as the chamber has adjourned for the August 2025 district work period. The U.S. Senate remains in session and continues to consider nominations...

United States Healthcare

HK

Holland & Knight

Potential False Claims Act Liability For Providers Of Gender-Affirming Care For Minors

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

Bio-Thera Announces Acceptance Of BLA For BAT2506 Referencing Johnson & Johnson's SIMPONI® (Golimumab)

On July 16, 2025, Bio-Thera Solutions, Ltd. announced that the U.S. Food and Drug Administration had accepted its Biologics License Application for its golimumab biosimilar, BAT2506, referencing Johnson & Johnson's SIMPONI®.

United States Healthcare

GP

Goodwin Procter LLP

DOJ And FTC Host Second Session On Structural And Regulatory Impediments To Drug Competition

On July 24, 2025, the Federal Trade Commission ("FTC") and the U.S. Department of Justice ("DOJ") convened the second of three public listening sessions aimed at identifying barriers...

United States Anti-trust

SM

Sheppard Mullin Richter & Hampton

DOJ False Claims "Working Group" Update

CYMI over the holiday week (present company included), the U.S. Department of Justice (DOJ) announced a re-energized partnership with the U.S. Department of Health and Human Services (HHS)...

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

PBMs Double Down On Cross Network Termination Over "Affiliated" Pharmacies

Pharmacy Benefit Managers (PBMs) have long dominated the independent pharmacy landscape with little oversight and expansive discretion.

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Executive Order To Combat Street Homelessness Calls For Expanding Involuntary Treatment And Institutionalization

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

FDA-Regulated Products Supply Chain Disruptions: Industry Perspective (Podcast)

United States Healthcare

B

BakerHostetler

Congress Expands Orphan Drug Exemptions From Medicare Price Negotiations

United States Healthcare

JD

Jones Day

California Construction Employers May Rely On Legal Exemption To Drug Test For Marijuana

United States Cannabis

JL

Jackson Lewis P.C.

Texas And Louisiana Serve Up New Laws On Food Product Labels And Disclosures

United States Healthcare

KM

Katten Muchin Rosenman LLP

Louisiana And Texas Pass Laws Requiring Warning Labels For Certain Food Ingredients

United States Healthcare

BD

Beveridge & Diamond

Joint RFI Issued For "Ultraprocessed" Definition

United States Technology

MB

Michael Best

Updates And News From The Bakerhostetler Life Sciences Team

United States Healthcare

B

BakerHostetler

MAHA Movement Continues To Invite Significant Change For Food Regulation At Federal And State Levels

United States Healthcare

KD

Kelley Drye & Warren LLP

FDA, HHS And USDA Serve Up Ultra-Processed Food RFI

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

Amgen And Accord BioPharma Settle Denosumab BPCIA Case

United States Healthcare

GP

Goodwin Procter LLP

Greenberg Glusker Corporate Partner Eric Perlmutter-Gumbiner Featured In LABJ Food & Beverage Roundtable

United States Commercial

GG

Greenberg Glusker Fields Claman & Machtinger

Building An Exemption: California Construction Employers Allowed To Drug Test For Marijuana

United States Healthcare

JL

Jackson Lewis P.C.

Microplastics Under The Microscope: Federal And California Proposals Target Microplastics

United States Healthcare

KG

K&L Gates LLP

Security Clearance Summertime Blues: Should You Self-Report?

United States Cannabis

TR

Tully Rinckey

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

JL

Jackson Lewis P.C.

Key Proposals In The CY2026 Medicare Advantage And Part D Proposed Rule (Video)

SM

Sheppard Mullin Richter & Hampton

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

The Human Resource: Marijuana vs. A Drug Policy (Video)

BT

Barnes & Thornburg

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