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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.

FDA Outlines "Plausible Mechanism" Approval Pathway For Personalized Therapies, But Significant Questions Remain

FDA Commissioner Martin Makary and Center for Biologics Evaluation and Research Director Vinay Prasad recently published an article in the New England Journal of Medicine ("NEJM") outlining the guiding principles of a new...

United States Healthcare

RG

Ropes & Gray LLP

Quilting Circle: The Growing Patchwork Of State Food + Consumer Product Regulation

State governments have entered an era of aggressive, uncoordinated rulemaking across the food, beverage, personal care, and packaging sectors.

United States Healthcare

DW

Davis Wright Tremaine

Food Venture Financing News – Weekly Issue No. 262

Gopuff, a leader in instant commerce, raised a $250 million funding round led by Eldridge Industries.

United States Healthcare

DW

Davis Wright Tremaine

FDA Issues First Draft Guidance In The Countdown To QMSR

On January 31, 2024, FDA issued the final rule revising 21 C.F.R. Part 820, which, upon taking effect, will be referred to as the Quality Management System Regulation (QMSR) (see our prior blog post here).

United States Healthcare

HP

Hyman, Phelps, & McNamara

Critical Medical Device Series: Part X Balancing Risk And Innovation: Fraud And Abuse Trends For MedTech (Video)

United States Healthcare

AP

Arnold & Porter

FDA Approves Accord BioPharma's Denosumab Biosimilars

United States Healthcare

GP

Goodwin Procter LLP

Operationalizing The Medical Frailty Exemption: A Step-by-Step Implementation Toolkit For States

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Bicameral, Bipartisan Bill Would Strengthen U.S. Biopharmaceutical Manufacturing

United States Healthcare

BC

Bergeson & Campbell

FDA Initiates Removal Of Warnings On Hormone Replacement Therapy

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Potential Alternatives To Address Health Care Affordability

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

FDA Accepts Sanofi And Regeneron's Dupixent SBLA For Priority Review

United States Healthcare

GP

Goodwin Procter LLP

Strategic Synergy At Atlantic Health: Saad Ehtisham On How Leadership Alignment Fuels Transformation (Video)

United States Healthcare

AM

Alvarez & Marsal

Congress Joins The Biomanufacturing Onshoring Party

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

Preparing For HRSA's 340B Rebate Model Pilot Program And The Beacon Platform

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

See more

Webinars

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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

mm

Mondaq

Recorded on 21 Jan 2025 | 3:00 PM

2025 Canadian In-House Counsel Report: Unparalleled Insights into Canada's In-House Profession from CCCA | Mondaq

TC

CBA In-House Lawyers

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Plausibility At The EPO – An Update On G2/21

United States Healthcare

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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

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Dehns

Supplementary Protection Certificates – European Patent Term Extensions

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Dehns

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

United States Healthcare

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Dehns

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

United States Healthcare

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Dehns

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

United States Healthcare

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Dehns

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

United States Healthcare

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Dehns

Best Practice For Invention Harvesting

United States Healthcare

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Dehns

Life Sciences, Biotechnology & Nanotechnology

FDA Issues First Draft Guidance In The Countdown To QMSR

On January 31, 2024, FDA issued the final rule revising 21 C.F.R. Part 820, which, upon taking effect, will be referred to as the Quality Management System Regulation (QMSR) (see our prior blog post here).

United States Healthcare

HP

Hyman, Phelps, & McNamara

DOJ Expands Health Care Fraud Strike Force To Massachusetts As Health Care Enforcement Remains An Administration Priority

The Department of Justice (DOJ) recently announced that it was expanding the Criminal Division's Health Care Fraud Unit's Strike Force (Strike Force) to the District of Massachusetts.

United States Criminal

LS

Lowenstein Sandler

Critical Medical Device Series: Part X Balancing Risk And Innovation: Fraud And Abuse Trends For MedTech (Video)

This session will provide an overview of the Federal Anti-Kickback Statute, focusing on emerging risks (and mitigation strategies) in the medical device industry.

United States Healthcare

AP

Arnold & Porter

FDA Approves Accord BioPharma's Denosumab Biosimilars

United States Healthcare

GP

Goodwin Procter LLP

Bicameral, Bipartisan Bill Would Strengthen U.S. Biopharmaceutical Manufacturing

United States Healthcare

BC

Bergeson & Campbell

FDA Accepts Sanofi And Regeneron's Dupixent SBLA For Priority Review

United States Healthcare

GP

Goodwin Procter LLP

Congress Joins The Biomanufacturing Onshoring Party

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

Sandoz Launches Natalizumab Biosimilar

United States Healthcare

GP

Goodwin Procter LLP

Sandoz And EirGenix Enter Licensing Agreement To Commercialize Proposed Pertuzumab Biosimilar

United States Healthcare

GP

Goodwin Procter LLP

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Healthcare

Food Venture Financing News – Weekly Issue No. 262

Gopuff, a leader in instant commerce, raised a $250 million funding round led by Eldridge Industries.

United States Healthcare

DW

Davis Wright Tremaine

DOJ Expands Health Care Fraud Strike Force To Massachusetts As Health Care Enforcement Remains An Administration Priority

The Department of Justice (DOJ) recently announced that it was expanding the Criminal Division's Health Care Fraud Unit's Strike Force (Strike Force) to the District of Massachusetts.

United States Criminal

LS

Lowenstein Sandler

Ninth Circuit: Employee's Secular Belief Not Entitled To Religious Protection Under Title VII

A request for accommodation must be rooted in a bona fide religious belief, not simply an employee's personal preference, the U.S. Court of Appeals...

United States Employment

MP

Manatt, Phelps & Phillips LLP

Operationalizing The Medical Frailty Exemption: A Step-by-Step Implementation Toolkit For States

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Bicameral, Bipartisan Bill Would Strengthen U.S. Biopharmaceutical Manufacturing

United States Healthcare

BC

Bergeson & Campbell

FDA Initiates Removal Of Warnings On Hormone Replacement Therapy

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Potential Alternatives To Address Health Care Affordability

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Europe's Increased Focus On The Environment And Corporate Sustainability: An Expensive Game Changer For The Pharma Industry

European Union Commercial

AO

A&O Shearman

Strategic Synergy At Atlantic Health: Saad Ehtisham On How Leadership Alignment Fuels Transformation (Video)

United States Healthcare

AM

Alvarez & Marsal

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Food and Drugs Law

FDA Outlines "Plausible Mechanism" Approval Pathway For Personalized Therapies, But Significant Questions Remain

FDA Commissioner Martin Makary and Center for Biologics Evaluation and Research Director Vinay Prasad recently published an article in the New England Journal of Medicine ("NEJM") outlining the guiding principles of a new...

United States Healthcare

RG

Ropes & Gray LLP

Quilting Circle: The Growing Patchwork Of State Food + Consumer Product Regulation

State governments have entered an era of aggressive, uncoordinated rulemaking across the food, beverage, personal care, and packaging sectors.

United States Healthcare

DW

Davis Wright Tremaine

Food Venture Financing News – Weekly Issue No. 262

Gopuff, a leader in instant commerce, raised a $250 million funding round led by Eldridge Industries.

United States Healthcare

DW

Davis Wright Tremaine

FDA Issues First Draft Guidance In The Countdown To QMSR

United States Healthcare

HP

Hyman, Phelps, & McNamara

DOJ Expands Health Care Fraud Strike Force To Massachusetts As Health Care Enforcement Remains An Administration Priority

United States Criminal

LS

Lowenstein Sandler

Operationalizing The Medical Frailty Exemption: A Step-by-Step Implementation Toolkit For States

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Bicameral, Bipartisan Bill Would Strengthen U.S. Biopharmaceutical Manufacturing

United States Healthcare

BC

Bergeson & Campbell

FDA Initiates Removal Of Warnings On Hormone Replacement Therapy

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Preparing For HRSA's 340B Rebate Model Pilot Program And The Beacon Platform

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

See more

Latest Videos

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Strategic Synergy At Atlantic Health: Saad Ehtisham On How Leadership Alignment Fuels Transformation (Video)

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Alvarez & Marsal

Album 9: Track 12 Steady On – Trilliant Health (Part 2) (Podcast)

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Polsinelli LLP

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

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Ropes & Gray LLP

WHLC Summit - Day One Recording (Video)

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Sheppard Mullin Richter & Hampton

Navigating Women's Health With Rachel Welch (Video)

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Offit Kurman

Upcoming Events

All In The Family - After The Wedding: AMC And Community Hospital Affiliations In Practice - American Health Law Association Academic Medical Centers Conference

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Buchanan Ingersoll & Rooney PC

The GENEROUS Model: What It Means For Life Science Companies, States And Patients

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ACI’s 8th Annual Summit On Life Sciences IP Due Diligence

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Foley Hoag LLP

Barracuda Bowl 2025

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Mintz

NEHEN: Fundraising At Inflection Points: How To Get It Right

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Foley Hoag LLP

ATA EDGE 2025 Policy Conference

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Foley & Lardner

State-Level Challenges And Initiatives Amid FDA Enforcement Discretion

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Holland & Knight

ACI 30th Annual Conference On Drug & Medical Device Litigation

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Crowell & Moring LLP

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