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European Union › Food and Drug Administration (FDA)

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Goodwin

Antitrust and Competition Life Sciences Quarterly Update Q2 2024

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To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more

Goodwin

STADA and Alvotech Announce Launch of UZPROVO® in Europe

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​​​​​​​On July 22, 2024, STADA Arzeimittel AG (“STADA”) and Alvotech announced the launch of ustekinumab biosimilar AVT04 under the name UZPROVO® across a majority of European countries. UZPROVO®, the first approved...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - June 2024

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Welcome to the June edition of Akin Intelligence. This month, the General Services Administration (GSA) launched its first AI-focused cohort of Presidential Innovation Fellows (PIF), bringing together experts from across the...more

WilmerHale

The Interplay Key Decisions at the Intersection of Antitrust and Life Sciences - June 2024

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Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more

Skadden, Arps, Slate, Meagher & Flom LLP

Insights – June 2024

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Explore the unique considerations for mergers and acquisitions in the AI sector, the return of IPOs, the implications of new Supreme Court decisions and other developments in this edition of Skadden’s quarterly Insights....more

NAVEX

A Look at the Whistleblowers Who Made Lasting Impacts

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As seen in the previous article, whistleblowing cases regularly make the news headlines. And while some of the names of the reporters or the cases are well known, it’s worthwhile to take a closer look at the people behind the...more

Knobbe Martens

UK Proposes Approving Medical Devices Based on Approval in Other Countries

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Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom.  On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

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HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

Clark Hill PLC

The Learned Concierge - March 2024, Vol. 6

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The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more

Sheppard Mullin Richter & Hampton LLP

Recent Healthcare-Related Artificial Intelligence Developments

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AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more

King & Spalding

FDA Aligns U.S. Medical Device Quality System Regulation with International Standards

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On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) and harmonizing them with...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

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As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

ArentFox Schiff

California Bans Several FDA-Authorized Food Additives; New York May Soon Follow

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On October 7, California Governor Gavin Newson signed into law AB-418, the California Food Safety Act, which completely bans, on safety grounds, the use in food of four additives that are considered safe by the US Food and...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

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FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Arnall Golden Gregory LLP

[Webinar] The Long and Winding Road: (Some) EU and FDA Issues to Consider With Clinical Trials and Clinical Agreements - September...

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Please join AGG Food & Drug co-chair Alan G. Minsk and Taylor Wessing Life Sciences and Healthcare attorneys Dr. Manja Epping and Irina Rebin for a complimentary webinar exploring the regulatory landscape of clinical trial...more

MoFo Life Sciences

The EU’S New Proposal For Plants Developed Using New Genomic Techniques: How Does It Compare To U.S. Regulation?

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After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post....more

Foley Hoag LLP

FDA Completes Second Premarket Consultation for Cultivated Meat Production, While Italy Bans Cell-Based Food

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Four months after completing its first premarket consultation, the Food and Drug Administration (FDA) cleared its second premarket consultation for cell-cultivated meat production. We wrote about the first premarket...more

Goodwin

US Artificial Intelligence Regulations: Watch List for 2023

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Companies are developing, deploying, and interacting with artificial intelligence (AI) technologies more than ever. At Goodwin, we are keeping a close eye on any regulations that may affect companies operating in this...more

Dechert LLP

Dechert Re:Torts Newsletter - Key Developments in Product Liability and Mass Torts - Issue 2

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Federal Appeals Court Dismisses Challenge to Interim PFAS Guidance, Leaving Important Questions Unresolved - A federal appeals court dismissed a challenge to EPA's interim guidance for PFAS levels in drinking water,...more

Morgan Lewis

The Trends—and Traps—that Will Shape 2023

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The last few years have thrown many surprises at businesses. Organizations across all sectors have faced inflation, global conflicts, supply chain challenges, a pandemic, and continually changing government policies. In 2023,...more

King & Spalding

Nearly a Century in the Making: Congress Modernizes FDA’s Regulation of Cosmetics

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The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more

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