News & Analysis as of

Medical Devices Pharmaceutical Industry Regulatory Agenda

McDermott Will & Emery

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

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The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

Jones Day

FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

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The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions....more

Quarles & Brady LLP

340B Developments in 2024 – Litigation and Legislation

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Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more

Goldberg Segalla

Will Industry Push Back Proactively on Potential PFAS-Use Restrictions?

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Over the past seven years, our blog has reported extensively on PFAS developments, litigation, and regulations — most of which has focused on the attention surrounding potential risks associated with PFAS, and the scrutiny...more

Polsinelli

FDA 2023-24: A Look Back & A Peek Forward

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Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more

Gardner Law

CMS Auditing Companies for Sunshine Compliance: Are You Ready?

Gardner Law on

As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting. Are you prepared for a Sunshine Act audit? Reporting...more

Smart & Biggar

2023 Highlights in Canadian Life Sciences IP and Regulatory Law

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Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more

Fenwick & West LLP

Navigating Healthcare Antitrust in the Biden Era

Fenwick & West LLP on

It’s no secret that Democrats are traditionally trustbusters, but the Biden Administration is taking things to a whole new level, bringing novel—and arguably weak—cases that nonetheless slow or block tie-ups among healthcare...more

Jones Day

Reversal of Burden of Proof Under Proposal for a New EU Product Liability Directive

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In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

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The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Knobbe Martens

PREVAIL Act Proposes Significant Changes PTAB Proceedings

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IP rights can be vital to the success of medical device companies.  Significant legislative changes governing some of these rights may be on the horizon.  Senators Coons (Delaware), Durbin (Illinois), Hirono (Hawaii), and...more

Nelson Mullins Riley & Scarborough LLP

FDA Revises Guidance Concerning Scientific Communications to HCPs about Unapproved Uses of Approved/Cleared Medical Products

The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Issues Long-Awaited Proposed Rule To Regulate Laboratory-Developed Tests

On September 29, 2023, the Food and Drug Administration (FDA) issued a proposed rule that would end its long-standing policy of enforcement discretion with respect to regulation of laboratory-developed tests (LDTs) (the...more

Nelson Mullins Riley & Scarborough LLP

FDA Proposes Drastic Overhaul of Laboratory Developed Test Regulation

Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | August 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

ArentFox Schiff on

Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

McDermott Will & Emery

Great Britain and European Union Timelines: What Are the Key Dates for Transition?

The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an...more

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance

The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 95

Jones Day on

This regular update (no. 95 | 9 January 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more

Jones Day

Covid-19 Key EU Developments, Policy & Regulatory Update No. 85

Jones Day on

COMPETITION & STATE AID - State Aid - European Commission approves new and amended Member State measures to support the economy - Since the onset of the coronavirus outbreak, the Commission has adopted a significant number...more

Knobbe Martens

FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program

Knobbe Martens on

On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement: FDA...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 80

Jones Day on

COMPETITION & STATE AID - State Aid - European Commission adopts Temporary Crisis Framework to support economy in context of Russia's invasion of Ukraine - On 23 March 2022, the Commission adopted a Communication on a...more

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