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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.

Q&A: FDA Seeks To Clarify '3-Year Exclusivity' With New Guidance

In March 2026, the Food and Drug Administration (FDA) issued draft guidance for the industry, New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers...

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

Streamlined And Sponsor-Friendly: What China's Amended Drug Regulations Mean For Pharma Companies

On January 27, 2026, China's State Council published the amended Implementing Regulations of the Drug Administration Law (the Regulations), which will take effect on May 15, 2026.

Worldwide Healthcare

AP

Arnold & Porter

A Reminder About Florida's Ban On Offshore Health Data Storage: What Providers And Vendors Should Know

In May 2023, Florida enacted a significant change to its health data laws. Senate Bill 264 amended the Florida Electronic Health Records Exchange Act restricting...

Worldwide Healthcare

JL

Jackson Lewis P.C.

HHS-OIG Issues Favorable Advisory Opinion On Discount Arrangement Between Medical Technology Manufacturer And Ambulatory Surgery Centers

The medical technology manufacturer and distributor (the requestor) offers products in numerous fields, including ophthalmology and microsurgery.

United States Healthcare

BT

Barnes & Thornburg LLP

Multi-Year Insurance Audits Of Physical Therapy Practices: Documentation, Medical Necessity, And The Growing Use Of Extrapolation

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

FDA Issues Draft Guidance On Responding To Form 483 Observations

United States Healthcare

AP

Arnold & Porter

Podcast - States Propose New Laws Affecting Healthcare Real Estate Investors And Owners

United States Healthcare

HK

Holland & Knight

FDA User Fee Act Reauthorization: What Happens Next And Positioning For Possible Reform

United States Healthcare

HK

Holland & Knight

DOJ's FCA Head Shares Enforcement Insights

United States Healthcare

SM

Sheppard, Mullin, Richter & Hampton LLP

OIG's Managed Care Compliance Roadmap: Key Risk Areas For Medicare Advantage

United States Healthcare

AP

Arnold & Porter

Efforts And Earnouts: Lessons From The Delaware Supreme Court In Johnson & Johnson v. Fortis

United States Healthcare

AP

Arnold & Porter

Optimism vs. Reality: Pressure Testing "But-for" Profit Models Used in Litigation

United States Healthcare

AC

Ankura Consulting Group LLC

FDA Issues Draft Guidance Further Streamlining Biosimilar Development

United States Healthcare

GP

Goodwin Procter LLP

Poisoned Trust: The Farid Fata Scandal (Podcast)

United States Healthcare

WR

Wiley Rein

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Webinars

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Recorded on 20 Jan 2026 | 3:00 PM

2026 Canadian In-House Counsel Report: Unparalleled Insights into Canada's In-House Profession from CBA In-House Lawyers

TC

CBA In-House Lawyers

Recorded on 24 Jun 2025 | 3:00 PM

(2nd Session) 2025 Global In-House Counsel Survey Report: Unique Insights into the Global In-House Counsel Profession

IC

In-House Counsel Worldwide

Recorded on 24 Jun 2025 | 9:00 AM

(1st Session) 2025 Global In-House Counsel Survey Report: Unique Insights into the Global In-House Counsel Profession

IC

In-House Counsel Worldwide

Recorded on 30 Apr 2025 | 2:00 PM

Mondaq | 2025 Law Firm Data Landscape Report

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Mondaq

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

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Dehns

How Good Does A Copy Need To Be?

United States Healthcare

D

Dehns

Supplementary Protection Certificates – European Patent Term Extensions

United States Healthcare

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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

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Dehns

Healthcare

A Reminder About Florida's Ban On Offshore Health Data Storage: What Providers And Vendors Should Know

In May 2023, Florida enacted a significant change to its health data laws. Senate Bill 264 amended the Florida Electronic Health Records Exchange Act restricting...

Worldwide Healthcare

JL

Jackson Lewis P.C.

IRS Issues Notice To Assist In Calculating The Qualifying Payment Amount For 2026

The Internal Revenue Service (IRS) has issued a notice providing the indexing factors that group health plans and health insurance issuers must...

United States Employment

HB

Hall Benefits Law

Streamlined And Sponsor-Friendly: What China's Amended Drug Regulations Mean For Pharma Companies

On January 27, 2026, China's State Council published the amended Implementing Regulations of the Drug Administration Law (the Regulations), which will take effect on May 15, 2026.

Worldwide Healthcare

AP

Arnold & Porter

HHS-OIG Issues Favorable Advisory Opinion On Discount Arrangement Between Medical Technology Manufacturer And Ambulatory Surgery Centers

United States Healthcare

BT

Barnes & Thornburg LLP

Multi-Year Insurance Audits Of Physical Therapy Practices: Documentation, Medical Necessity, And The Growing Use Of Extrapolation

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

AKS, Stark, EKRA, And Self-Disclosure Walked Into A Panel …

United States Criminal

AP

Arnold & Porter

Podcast - States Propose New Laws Affecting Healthcare Real Estate Investors And Owners

United States Healthcare

HK

Holland & Knight

FDA User Fee Act Reauthorization: What Happens Next And Positioning For Possible Reform

United States Healthcare

HK

Holland & Knight

DOJ's FCA Head Shares Enforcement Insights

United States Healthcare

SM

Sheppard, Mullin, Richter & Hampton LLP

See more

Life Sciences, Biotechnology & Nanotechnology

FDA Moves To Streamline Biosimilar Development: The Implications For Regulatory And IP Strategy

The FDA issued updated guidance on the requirements for biosimilar sponsors seeking to use foreign comparator products in clinical studies.

United States IP

SA

Skadden Arps Slate Meagher & Flom

Federal Circuit Refuses To Construe "Configured For" As More Than "Capable Of"

In In re Blue Buffalo Enterprises, Inc., No. 2024-1611 (Fed. Cir. Jan. 14, 2026), the Federal Circuit affirmed the PTAB's decision affirming the Examiner's obviousness...

United States IP

OM

Oblon, McClelland, Maier & Neustadt, L.L.P

The Doctrine Of Inherency In The Context Of An Obviousness Analysis

In this board decision, the Patent Trial and Appeal Board (PTAB) reversed the Examiner's rejections of claims 22, 54-56, and 60-62 in US 16/765,024.

United States IP

OM

Oblon, McClelland, Maier & Neustadt, L.L.P

Patenting AI Discoveries In Life Sciences: Overcoming Eligibility, Disclosure, And Inventorship Challenges

United States IP

TS

Taft Stettinius & Hollister

Essential Reading For Plant IP Enthusiasts: Nador Cott Protection SAS V Asda Stores Limited – [2026] EWHC 553 (Pat)

United States IP

JA

J A Kemp LLP

FDA User Fee Act Reauthorization: What Happens Next And Positioning For Possible Reform

United States Healthcare

HK

Holland & Knight

Navigating The 2026 Life Sciences Legal Landscape

United States Healthcare

AF

ArentFox Schiff

Optimism vs. Reality: Pressure Testing "But-for" Profit Models Used in Litigation

United States Healthcare

AC

Ankura Consulting Group LLC

Efforts And Earnouts: Lessons From The Delaware Supreme Court In Johnson & Johnson v. Fortis

United States Healthcare

AP

Arnold & Porter

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Food and Drugs Law

FDA Moves To Streamline Biosimilar Development: The Implications For Regulatory And IP Strategy

The FDA issued updated guidance on the requirements for biosimilar sponsors seeking to use foreign comparator products in clinical studies.

United States IP

SA

Skadden Arps Slate Meagher & Flom

Countdown To April 13: What NJ Hemp Product Operators Must Do To Avoid Penalties And Retain Market Share

New Jersey is entering a decisive phase in its regulation of hemp-derived cannabinoid products, and operators across the supply chain now face a compressed timeline to align their businesses...

United States Cannabis

SH

Scarinci Hollenbeck LLC

The Delta-8 Dilemma: What Mississippi Employers (And Maybe Those In Other States) Need To Know About Drug Testing Policies And THC Products

Walk into many convenience stores across the country, and you'll likely see gummies, vapes, and tinctures labeled "Delta-8."...

United States Cannabis

BA

Bradley Arant Boult Cummings LLP

Q&A: FDA Seeks To Clarify '3-Year Exclusivity' With New Guidance

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

The Doctrine Of Inherency In The Context Of An Obviousness Analysis

United States IP

OM

Oblon, McClelland, Maier & Neustadt, L.L.P

Streamlined And Sponsor-Friendly: What China's Amended Drug Regulations Mean For Pharma Companies

Worldwide Healthcare

AP

Arnold & Porter

FDA Issues Draft Guidance On Responding To Form 483 Observations

United States Healthcare

AP

Arnold & Porter

ERISA Class Action on Prescription Drug Benefits Gets Green Light — A Warning for Plan Sponsors

United States Employment

BI

Buchanan Ingersoll & Rooney PC

FDA User Fee Act Reauthorization: What Happens Next And Positioning For Possible Reform

United States Healthcare

HK

Holland & Knight

See more

Latest Videos

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In The Know: The Clean Beauty Trend Becomes State Law (Video)

LL

Loeb & Loeb LLP

GT Legal Food Talk Episode 30: Navigating Liquor Licensing: Inside The Legal Food & Beverage Landscape (Podcast)

GT

Greenberg Traurig, LLP

Leaders In Law: Life Sciences And Technology Transactions With Jekkie Kim (Podcast)

W

WilmerHale

Digging Into New York's New Price-Gouging Rules (Video)

BS

Bond, Schoeneck & King PLLC

Pay Transparency + The Power Of Preventive Strategies: Episode 3 — Pivoting Toward Preparation In The Life Sciences (Video)

JL

Jackson Lewis P.C.

Upcoming Events

New CMS Rural Health Transformation Program: Purpose, Funding Eligibility And Allocation, Healthcare Provider Impact

United States Healthcare

FH

Foley Hoag LLP

Capital Connect: From Seed To Series A In Today’s Market

United States Healthcare

FL

Foley & Lardner

Healthy AI Forum

United States Healthcare

SM

Sheppard, Mullin, Richter & Hampton LLP

Marsh Health Tech Symposium

United States Healthcare

SM

Sheppard, Mullin, Richter & Hampton LLP

Virtual Forty-Third National HIPAA Summit

United States Healthcare

HK

Holland & Knight

11th Annual Songwriters' Night

United States Healthcare

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Bass, Berry & Sims

Exploring The Subtleties And Safe Zones Of Off-Label Communications — Part 2

United States Healthcare

FL

Foley & Lardner

MassBio State Of Possible Conference

United States Healthcare

FH

Foley Hoag LLP

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