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.

CRLs Unveiled: Converting FDA Transparency Into A Market Advantage

With the FDA's disclosure of 200 Complete Response Letters (CRLs), leadership teams now have an unprecedented insight into regulatory decision-making to glean patterns...

United States Healthcare

AM

Alvarez & Marsal

New York Court Of Appeals Upholds Long-Standing Tort Law Regarding Medical Malpractice Damages

On Oct. 21, 2025, in SanMiguel v. Grimaldi, the New York Court of Appeals reaffirmed a well settled rule of tort law that limits recovery of purely emotional damages in prenatal injury cases.

United States Healthcare

GT

Greenberg Traurig, LLP

New Drug Approvals: "Human Organ-on-a-Chip" GAO Report Supports Innovation And Regulatory Policy For Non-Animal Models

Animal models remain foundational to biomedical research, having contributed to the development of vaccines, drugs, and surgical innovations. But their continued use faces growing scrutiny due to ethical concerns...

United States Healthcare

FL

Foley & Lardner

Holland & Knight Health Dose: October 28, 2025

In a notable development, a group of moderate Republican members of the U.S. House of Representatives sent a letter to Speaker Mike Johnson (R-La.), urging him to initiate negotiations on extending the APTCs but only after the government has reopened

United States Healthcare

HK

Holland & Knight

Healthcare Trends & Transactions Q3 2025

United States Healthcare

BB

Bass, Berry & Sims

Illinois To Require Illinois-Licensed PICs For Nonresident Pharmacies Effective January 1, 2026

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

ATA EDGE 2025 Policy Conference

United States Healthcare

FL

Foley & Lardner

Virtual And Digital Health Digest

Worldwide Healthcare

AP

Arnold & Porter

Open Season Nears: Advanced Premium Tax Credits And Potential Paths Forward

United States Healthcare

HK

Holland & Knight

CLIA Program Going Paperless March 1st – What You Should Be Doing Now To Prepare

United States Healthcare

PL

Polsinelli LLP

FDA Presses Forward On Patient-Focused Drug Development, Releases Final Guidance Focused On Fit-For-Purpose Clinical Outcome Assessments

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

The Big, Beautiful Webinar Series: Strategic Planning For Post-Acute/LTC Providers (Video)

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

Pa. Supreme Court Clarifies Scope Of MHPA Immunity

United States Healthcare

SS

Saxton & Stump

Key Takeaways From The 9th Annual Pharmacy, Pharma Services & 340B Conference

United States Healthcare

BB

Bass, Berry & Sims

Tariffs, Contracts And The Negotiation Imperative: Why The Old Playbook Won't Work

United States International

J

JAMS

Greenwashing Legislation Trends: Key Takeaways For Businesses

Worldwide Commercial

RG

Ropes & Gray LLP

District Court Invalidates Patents For Bridge Cheating Detection Software Under § 101

United States IP

JM

Jeffer Mangels Butler & Mitchell LLP

U.S. Immigration Updates – October 2025

Worldwide Immigration

K

Klasko

USCIS Announces Changes To The Naturalization Test

United States Immigration

Gs

Green and Spiegel

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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

CRLs Unveiled: Converting FDA Transparency Into A Market Advantage

With the FDA's disclosure of 200 Complete Response Letters (CRLs), leadership teams now have an unprecedented insight into regulatory decision-making to glean patterns...

United States Healthcare

AM

Alvarez & Marsal

U.S. Sanctions Colombia's President Under Global Illicit Drug Trade Program

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) has designated Colombia's sitting president, Gustavo Francisco Petro Urrego, under Executive Order 14059, which imposes sanctions on foreign persons involved in the global illicit drug trade.

United States International

HK

Holland & Knight

New Drug Approvals: "Human Organ-on-a-Chip" GAO Report Supports Innovation And Regulatory Policy For Non-Animal Models

Animal models remain foundational to biomedical research, having contributed to the development of vaccines, drugs, and surgical innovations. But their continued use faces growing scrutiny due to ethical concerns...

United States Healthcare

FL

Foley & Lardner

Holland & Knight Health Dose: October 28, 2025

United States Healthcare

HK

Holland & Knight

Illinois To Require Illinois-Licensed PICs For Nonresident Pharmacies Effective January 1, 2026

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Open Season Nears: Advanced Premium Tax Credits And Potential Paths Forward

United States Healthcare

HK

Holland & Knight

FDA Presses Forward On Patient-Focused Drug Development, Releases Final Guidance Focused On Fit-For-Purpose Clinical Outcome Assessments

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

This Week From The Hill (October 26 – November 1, 2025)

United States Employment

GL

Groom Law Group

Trump Administration Targets PBM Reform To Lower Drug Prices

United States Healthcare

HB

Hall Benefits Law

See more

Life Sciences, Biotechnology & Nanotechnology

CRLs Unveiled: Converting FDA Transparency Into A Market Advantage

With the FDA's disclosure of 200 Complete Response Letters (CRLs), leadership teams now have an unprecedented insight into regulatory decision-making to glean patterns...

United States Healthcare

AM

Alvarez & Marsal

Holland & Knight Health Dose: October 28, 2025

In a notable development, a group of moderate Republican members of the U.S. House of Representatives sent a letter to Speaker Mike Johnson (R-La.), urging him to initiate negotiations on extending the APTCs but only after the government has reopened

United States Healthcare

HK

Holland & Knight

ATA EDGE 2025 Policy Conference

On December 10-12, Foley partners Nathaniel Lacktman, Nathan Beaver, T.J. Ferrante, and Aaron Maguregui are speaking in the American Telemedicine Association's (ATA) EDGE 2025...

United States Healthcare

FL

Foley & Lardner

Replay: Wearables Webinar Series, Part 2: Cybersecurity And Data Privacy Concerns For Wearables (Video)

United States Privacy

DM

Duane Morris LLP

NIH New Patent Licensing Policy

United States IP

TC

Thompson Coburn LLP

AI In Health Care And Biotechnology: Promise, Progress, And Challenges

United States Healthcare

FL

Foley & Lardner

Recent Rulings Highlight Risk To Japanese Drugmakers In Settling Pharmaceutical Litigations

United States Healthcare

JB

Jenner & Block

Payers, Providers, And Patients – Oh My!: AI In Healthcare – Key Policy Developments And State Laws

United States Technology

CM

Crowell & Moring LLP

Xbrane Enters Into Conditional Financing Deal Related To Ranibizumab Biosimilar

United States Healthcare

GP

Goodwin Procter LLP

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Healthcare

Joint Commission And Coalition For Health AI Release First-of-Its-Kind Guidance On Responsible AI Use In Healthcare

The Joint Commission and the Coalition for Health AI released a new framework, the Responsible Use of AI in Healthcare (RUAIH), to guide safe, ethical adoption of AI tools in clinical and operational settings.

United States Technology

PL

Polsinelli LLP

New York Court Of Appeals Upholds Long-Standing Tort Law Regarding Medical Malpractice Damages

On Oct. 21, 2025, in SanMiguel v. Grimaldi, the New York Court of Appeals reaffirmed a well settled rule of tort law that limits recovery of purely emotional damages in prenatal injury cases.

United States Healthcare

GT

Greenberg Traurig, LLP

Holland & Knight Health Dose: October 28, 2025

In a notable development, a group of moderate Republican members of the U.S. House of Representatives sent a letter to Speaker Mike Johnson (R-La.), urging him to initiate negotiations on extending the APTCs but only after the government has reopened

United States Healthcare

HK

Holland & Knight

Healthcare Trends & Transactions Q3 2025

United States Healthcare

BB

Bass, Berry & Sims

ATA EDGE 2025 Policy Conference

United States Healthcare

FL

Foley & Lardner

The Value Of Sitting Second Chair: Lessons From The Counsel Table

United States Litigation

Shaub, Ahmuty, Citrin & Spratt LLP

Virtual And Digital Health Digest

Worldwide Healthcare

AP

Arnold & Porter

Replay: Wearables Webinar Series, Part 2: Cybersecurity And Data Privacy Concerns For Wearables (Video)

United States Privacy

DM

Duane Morris LLP

Open Season Nears: Advanced Premium Tax Credits And Potential Paths Forward

United States Healthcare

HK

Holland & Knight

See more

Latest Videos

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Navigating Health Plan M&A: Strategies For Success In The Medicare Advantage Market (Podcast)

RG

Ropes & Gray LLP

WHLC Summit - Day Two Recording (Video)

SM

Sheppard Mullin Richter & Hampton

Redefining Healthcare Leadership: Dr. Heather Farley On The Inaugural Role Of Chief Well-being Officer At MUSC (Video)

AM

Alvarez & Marsal

The Journey To Better Healthcare With Ben Kruger (Video)

OK

Offit Kurman

Inside MedTech Translation Challenges: Ensuring Multilingual Regulatory Compliance

Moringside

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