News & Analysis as of

Manufacturer Liability Life Sciences

Napoli Shkolnik

Product Liability: How it Works For and Against Victims of Defective Medical Devices

Napoli Shkolnik on

Crafting the perfect medical device is never an exact science—but a patient should never suffer because of defects in a product that was intended to improve their quality of life. Determining whether a device manufacturer or...more

Knobbe Martens

Enovis Corp. Acquires LimaCorporate for $846 Million

Knobbe Martens on

Enovis Corporation (“Enovis”) announced on September 25, 2023, that it has agreed to acquire LimaCorporate S.p.A (“LimaCorporate”)....more

Knobbe Martens

Major Med Device Product Developer GE HealthCare Collaborating with Healthcare Providers

Knobbe Martens on

For good reasons, including product safety, quality assurance, development of delivery procedures and instructions, it has been a common practice for medical device companies and innovators to consult with physicians during...more

Hogan Lovells

The next era of digital therapeutics

Hogan Lovells on

Products incorporating artificial intelligence/machine learning (AI/ML) algorithms have enormous potential for health care. The power of AI can enhance the capabilities of software that has the potential to benefit more...more

Epstein Becker & Green

FDA Releases Proposed Rule on National Standards for Drug Wholesaler Licensure

On February 4, 2022—more than six years after the deadline imposed by statute—the U.S. Food and Drug Administration (“FDA”) issued a proposed rule titled “National Standards for the Licensure of Wholesale Drug Distributors...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 7th - 8th, New York, NY

The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more

Butler Snow LLP

Looking Beyond the Pandemic – AI and Digital Health Kick into Warp Speed

Butler Snow LLP on

What This Means for the FDA and the Industry - The COVID-19 pandemic has spurred the development of digital health products utilizing artificial intelligence (AI) and machine learning (ML). When the pandemic passes, there...more

Epstein Becker & Green

Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast

Epstein Becker & Green on

This Diagnosing Health Care episode looks at the adjustments to business operations and compliance programs that pharmaceutical and medical device companies need to consider as they launch new products during the ongoing...more

Hogan Lovells

The Court of Justice of the European Union provides clarifications on the assessment under competition law of pay-for-delay deals...

Hogan Lovells on

On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more

Faegre Drinker Biddle & Reath LLP

FDA Warns Companies about Processing, Distributing and Marketing Unapproved Stem Cell Products

The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing,...more

American Conference Institute (ACI)

[Event] Drug and Medical Device Litigation – the Must-Attend Event for the Life Sciences Products Liability Community - December...

Actionable Strategies for Drug and Medical Device Products Liability Litigators and In-house Counsel - ACI’s Drug and Medical Device Litigation conference is the only event which brings together an exceptional in-house...more

Patrick Malone & Associates P.C. | DC Injury...

After thousands of lawsuits, FDA bans mesh used in pelvic prolapse procedures

After years of patient complaints about injuries and tens of thousands of lawsuits, the federal Food and Drug Administration yanked from the market a surgical mesh widely used to repair pelvic conditions in women....more

King & Spalding

FDA’s Focus on Devices Impacting Women’s Health is Fully Underway: Breast Implant Advisory Set for March 25-26

King & Spalding on

Late last year, the Food and Drug Administration’s (FDA’s) Device Center announced a new objective when it comes to devices – “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and...more

Hogan Lovells

The Crackdown Continues:  FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety...

Hogan Lovells on

Last week, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing...more

14 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide