United States: Food, Drugs, Healthcare, Life Sciences

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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.

AI-llowed Or Infringing? Are AI Research Tools Protected Under The Safe Harbor?

As artificial intelligence (AI) continues to transform pharmaceutical and medical device innovation, legal questions may emerge around its role in preclinical and regulatory research.

United States Healthcare

AP

Arnold & Porter

DOJ-HHS Announces False Claims Act Working Group, Emphasizes Healthcare Fraud Enforcement Priorities

The Trump administration recently announced the renewal of a new cross-agency collaboration between the Department of Justice (DOJ) and the Department of Health and Human Services (HHS)...

United States Healthcare

GP

Goodwin Procter LLP

Eight Ways ACA Marketplaces Should Be Leveraging AI To Manage New H.R.1 Requirements

On July 4, the president signed budget reconciliation legislation, H.R. 1 into law. Prior to this signing, on June 20th , the Centers for Medicare and Medicaid (CMS)...

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Why 340B Data Must Be Part Of CMS's Medicaid Pharmacy Surveys

As The Centers for Medicare & Medicaid Services (CMS) builds its Medicaid pharmacy survey tools as required by the One Big Beautiful Bill...

United States Healthcare

JW

Jones Walker

FDA Warning Letter Reminds Industry That Wellness Claims Only Go So Far, Other Features Can Establish Intended Use

United States Healthcare

M

Mintz

In Case Of First Impression, Looking To AKS Precedent, Ninth Circuit Affirms EKRA Conviction For Improper Payments To Marketers

United States Healthcare

B

BakerHostetler

Looking At The Challenges Of AI In Life Sciences

United States Healthcare

C

Crowley Law LLC

Building The Future Of Biopharmaceutical Manufacturing: Insights From BioNJ Manufacturing Briefing 2024

United States Healthcare

C

Crowley Law LLC

Looking At The Challenges Of AI In Life Sciences

United States Healthcare

C

Crowley Law LLC

No Rest For The Caretakers: Health Care Industry In Crosshairs For Expanded False Claims Act And Criminal Enforcement Activity

United States Healthcare

KL

Herbert Smith Freehills Kramer LLP

CMS Releases CY 2026 Outpatient Prospective, ASC Payment System Proposed Rule

United States Healthcare

HK

Holland & Knight

AI In Biotech Research: Boon Or Bane?

United States Healthcare

C

Crowley Law LLC

Pulse Check: How Is Your California Practice Leveraging "103 NPs" – And Preparing For The Arrival Of "104 NPs" In 2026?

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

Victory For DMEPOS Provider: Buchanan Reverses Medicare Enrollment Revocation

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

New Montana State Income And Property Taxes For 2025 & 2026

United States Tax

PB

Parsons Behle & Latimer

Trump's Plan B For Tariffs

United States International

BG

Braumiller Law Group, PLLC

U.S.-China Trade Relations: An Update On Tariffs

United States International

BG

Braumiller Law Group, PLLC

Tariffs And The Future Of U.S. Beef

United States International

BG

Braumiller Law Group, PLLC

From Copyright Case To AI Data Crisis: How The New York Times v. OpenAI Reshapes Companies' Data Governance And EDiscovery Strategy

United States Technology

NM

Nelson Mullins Riley & Scarborough LLP

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Highlighted Content

Plausibility At The EPO – An Update On G2/21

United States Healthcare

D

Dehns

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

How Good Does A Copy Need To Be?

United States Healthcare

D

Dehns

Supplementary Protection Certificates – European Patent Term Extensions

United States Healthcare

D

Dehns

How Much Experimental Data Is Needed For Patent Applications In Europe?

United States Healthcare

D

Dehns

The Silent Treatment: The EPO's Approach To Non-therapeutic Methods Encompassing Therapeutic Effects

United States Healthcare

D

Dehns

Implications Of The Genetic Technology (Precision Breeding) Bill On The Life Science IP Sector

United States Healthcare

D

Dehns

Protection For Plant Varieties In Europe And The UK Post-Brexit

United States Healthcare

D

Dehns

Best Practice For Invention Harvesting

United States Healthcare

D

Dehns

Food and Drugs Law

AI-llowed Or Infringing? Are AI Research Tools Protected Under The Safe Harbor?

As artificial intelligence (AI) continues to transform pharmaceutical and medical device innovation, legal questions may emerge around its role in preclinical and regulatory research.

United States Healthcare

AP

Arnold & Porter

FTC Uses Its Consumer Protection Powers To Regulate Sellers Of GLP-1s

On July 14, 2025, the FTC announced its enforcement action against telemedicine company NextMed over charges it used misleading prices, fake reviews and deceptive weight-loss claims to sell GLP-1 weight-loss drugs.

United States Consumer

CM

Crowell & Moring LLP

DOJ-HHS Announces False Claims Act Working Group, Emphasizes Healthcare Fraud Enforcement Priorities

The Trump administration recently announced the renewal of a new cross-agency collaboration between the Department of Justice (DOJ) and the Department of Health and Human Services (HHS)...

United States Healthcare

GP

Goodwin Procter LLP

Why 340B Data Must Be Part Of CMS's Medicaid Pharmacy Surveys

United States Healthcare

JW

Jones Walker

FDA Warning Letter Reminds Industry That Wellness Claims Only Go So Far, Other Features Can Establish Intended Use

United States Healthcare

M

Mintz

Looking At The Challenges Of AI In Life Sciences

United States Healthcare

C

Crowley Law LLC

Looking At The Challenges Of AI In Life Sciences

United States Healthcare

C

Crowley Law LLC

CMS Releases CY 2026 Outpatient Prospective, ASC Payment System Proposed Rule

United States Healthcare

HK

Holland & Knight

CBP Rescinds PGA Filing Exemption For Certain Low-Value FDA-Regulated Products

United States International

CM

Crowell & Moring LLP

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Life Sciences, Biotechnology & Nanotechnology

AI-llowed Or Infringing? Are AI Research Tools Protected Under The Safe Harbor?

As artificial intelligence (AI) continues to transform pharmaceutical and medical device innovation, legal questions may emerge around its role in preclinical and regulatory research.

United States Healthcare

AP

Arnold & Porter

DOJ-HHS Announces False Claims Act Working Group, Emphasizes Healthcare Fraud Enforcement Priorities

The Trump administration recently announced the renewal of a new cross-agency collaboration between the Department of Justice (DOJ) and the Department of Health and Human Services (HHS)...

United States Healthcare

GP

Goodwin Procter LLP

Why 340B Data Must Be Part Of CMS's Medicaid Pharmacy Surveys

As The Centers for Medicare & Medicaid Services (CMS) builds its Medicaid pharmacy survey tools as required by the One Big Beautiful Bill...

United States Healthcare

JW

Jones Walker

Looking At The Challenges Of AI In Life Sciences

United States Healthcare

C

Crowley Law LLC

Building The Future Of Biopharmaceutical Manufacturing: Insights From BioNJ Manufacturing Briefing 2024

United States Healthcare

C

Crowley Law LLC

Looking At The Challenges Of AI In Life Sciences

United States Healthcare

C

Crowley Law LLC

No Rest For The Caretakers: Health Care Industry In Crosshairs For Expanded False Claims Act And Criminal Enforcement Activity

United States Healthcare

KL

Herbert Smith Freehills Kramer LLP

CBP Rescinds PGA Filing Exemption For Certain Low-Value FDA-Regulated Products

United States International

CM

Crowell & Moring LLP

Cybersecurity Challenges And Data Protection Strategies For Life Sciences And Tech Companies

United States Technology

C

Crowley Law LLC

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Healthcare

The (Less-Than-Golden) State Of Confidentiality Provisions In California

It is well known that California takes a dim view towards restrictive covenants in the workplace. Business & Professions Code Section 16600 prohibits employee non-compete agreements...

United States Employment

LM

Littler Mendelson

DOJ-HHS Announces False Claims Act Working Group, Emphasizes Healthcare Fraud Enforcement Priorities

The Trump administration recently announced the renewal of a new cross-agency collaboration between the Department of Justice (DOJ) and the Department of Health and Human Services (HHS)...

United States Healthcare

GP

Goodwin Procter LLP

Eight Ways ACA Marketplaces Should Be Leveraging AI To Manage New H.R.1 Requirements

On July 4, the president signed budget reconciliation legislation, H.R. 1 into law. Prior to this signing, on June 20th , the Centers for Medicare and Medicaid (CMS)...

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Why 340B Data Must Be Part Of CMS's Medicaid Pharmacy Surveys

United States Healthcare

JW

Jones Walker

FDA Warning Letter Reminds Industry That Wellness Claims Only Go So Far, Other Features Can Establish Intended Use

United States Healthcare

M

Mintz

In Case Of First Impression, Looking To AKS Precedent, Ninth Circuit Affirms EKRA Conviction For Improper Payments To Marketers

United States Healthcare

B

BakerHostetler

In NH And Mass. Can Corporations Be Doctors Too?

United States Employment

MM

McLane Middleton, Professional Association

Looking At The Challenges Of AI In Life Sciences

United States Healthcare

C

Crowley Law LLC

No Rest For The Caretakers: Health Care Industry In Crosshairs For Expanded False Claims Act And Criminal Enforcement Activity

United States Healthcare

KL

Herbert Smith Freehills Kramer LLP

See more

Patents

The "Lead Compound" Approach To Obviousness And Obviousness-Type Double Patenting

In Otsuka Pharmaceutical Co. v. Sandoz, Inc., the Federal Circuit upheld the district court’s determination that the claims at issue were neither obvious nor invalid under the doctrine of obviousness-type double patenting based on a "lead compound" approach to the obviousness determinations.

United States IP

FL

Foley & Lardner

With Ultramercial Remand, Is The Supreme Court Telegraphing View On Patent Eligibility To Federal Circuit?

After the Supreme Court decided that the personalized medicine method claims at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc. did not satisfy the patent eligibility requirements of 35 USC § 101.

United States IP

FL

Foley & Lardner

GSK And Genentech Settle Cabilly Patent Lawsuit

GlaxoSmithKline and Genentech have settled a U.S. lawsuit related to Genentech's Cabilly II (US 6,331,415) and Cabilly III (US 7,923,221) patents.

United States IP

BR

Beeser Ramamoorthy LLP

Supreme Court Holds That Generic Drug Manufacturers Can Challenge The Validity Of A Reference Drug’s "Use Code"

United States IP

BA

Bradley Arant Boult Cummings LLP

U.S. Supreme Court Allows Generic Drug Manufacturers To Challenge Brand’s FDA Use Codes

United States IP

VE

Vinson & Elkins LLP

Supreme Court Allows Generics To Challenge Orange Book Use Codes In Hatch-Waxman Litigation

United States Healthcare

PH

Paul Hastings LLP

Supreme Court Sides With Generic Drug Manufacturers, Closes Loophole In Hatch-Waxman Act

United States IP

PC

Perkins Coie LLP

U.S. Supreme Court Remands Myriad Case In Light Of Its Decision In Prometheus

United States IP

VE

Vinson & Elkins LLP

Federal Circuit Articulates Facts Establishing Jurisdiction In Declaratory Judgment Actions

United States IP

VE

Vinson & Elkins LLP

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Latest Videos

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Navigating FDA Compliance And Civil Litigation: Strategies For Food And Medical Product Companies (Video)

AP

Arnold & Porter

Artificial Intelligence In Healthcare (Video)

BI

Buchanan Ingersoll & Rooney PC

DSO Market Trends And 2025 Outlook ADSO Webinar Recording (Video)

B

Benesch Friedlander Coplan & Aronoff LLP

Safeguarding Trust: Preventing Theft In Assisted Living Facilities (Video)

JL

Jackson Lewis P.C.

Inside The World Of Long-Term Care Certificate Of Need (CON) (Video)

SM

Sheppard Mullin Richter & Hampton

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