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.

FDA Issues First Draft Guidance In The Countdown To QMSR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)

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

On November 20, 2025, the FDA approved Accord BioPharma's denosumab biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), which reference Amgen's PROLIA® and XGEVA®, respectively.

United States Healthcare

GP

Goodwin Procter LLP

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

The enactment of H.R.1 introduces mandatory work reporting requirements for Medicaid expansion adults, while explicitly exempting individuals who are medically frail.

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

Medicare Finalizes 3.8% Physician Reimbursement Increase

United States Healthcare

AC

Ankura Consulting Group LLC

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

Banking Industry Outlook: U.S. Banking M&A Surge Arrives In Q3

United States Compliance

AC

Ankura Consulting Group LLC

What Honeybees Have Taught Me About Dispute Resolution

United States Litigation

J

JAMS

One Size Doesn't Fit All: Customizing Dispute Resolution For Commercial Contracts

United States Litigation

J

JAMS

From Conflict To Clarity: Why The ADR Experience Matters In Successful Resolution

United States Litigation

J

JAMS

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

United States International

J

JAMS

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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

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

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

The enactment of H.R.1 introduces mandatory work reporting requirements for Medicaid expansion adults, while explicitly exempting individuals who are medically frail.

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

Pharmacy Benefit Managers Ask Appeals Panel To Send Case Against FTC To Federal Court

United States Healthcare

DM

Duane Morris LLP

FDA In Flux — November 2025 Newsletter

United States Healthcare

M

Mintz

Reforming GRAS: Digesting The Proposed "Better Food Disclosure Act" (S. 3122)

United States Healthcare

WR

Wiley Rein

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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

See more

Healthcare

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

The enactment of H.R.1 introduces mandatory work reporting requirements for Medicaid expansion adults, while explicitly exempting individuals who are medically frail.

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

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

See more

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

AP

Arnold & Porter

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

AM

Alvarez & Marsal

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

PL

Polsinelli LLP

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

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