News & Analysis as of October 31, 2024

Draft Guidance

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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +

FTC Comment on FDA Draft Guidance on Interchangeability

Goodwin on 8/29/2024

We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more

Antitrust & Competition Technology Quarterly Update - Q2 2023

Goodwin on 8/25/2023

Antitrust enforcers remained active across the globe, with the announcement by the FTC and DOJ of proposed guidelines that have an emphasis on tech mergers in the United States, and several investigations of major tech deals...more

A Big Deal: FTC and DOJ Issue Long-Awaited New Draft Merger Guidelines

Sheppard Mullin Richter & Hampton LLP on 7/21/2023

On July 19, 2023, the Federal Trade Commission and Department of Justice jointly published long-anticipated proposed merger guidelines (the “Proposed Merger Guidelines”), which had been expected since President Biden issued...more

The Buzz on Med Device Cybersecurity

Gardner Law on 12/20/2022

Medical device cybersecurity continues to create buzz, as the FBI issues a Private Industry Notification to health care providers outlining cybersecurity risks for medical devices. This follows FDA’s released Draft Guidance...more

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on 12/2/2022

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Privacy & Cybersecurity Update - January 2021

Skadden, Arps, Slate, Meagher & Flom LLP on 2/4/2021

In this month's edition, we examine the European Commission's Digital Services Act and its potential regulatory impact, the National Institute of Standards and Technology's draft guidance on internet-of-things devices'...more

Privacy & Cybersecurity Update - December 2019

Skadden, Arps, Slate, Meagher & Flom LLP on 1/3/2020

In this month's edition of our Privacy & Cybersecurity Update, we take a look at guidance on artificial intelligence released by the U.K. Information Commissioner's Office and the Turing Institute, as well as guidance...more

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