Popular, Draft Guidance

FTC Comment on FDA Draft Guidance on Interchangeability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We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to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

Clinical Trials: FDA Publishes Draft Guidance on Diversity Action Plans

Foley & Lardner LLP on 7/26/2024

On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more

FDA's View on Cannabis

Gardner Law on 4/3/2024

The U.S. Food and Drug Administration (FDA) is continuing to support clinical research for cannabis and psychedelic drug development. On the heels of publishing its first draft guidance on clinical trials involving...more

Vital Signs: Digital Health Law Update | Winter 2024

Jones Day on 3/20/2024

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more

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

Goodwin on 1/4/2024

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

Dechert Re:Torts - Key Developments in Product Liability and Mass Torts - Issue 11

Dechert LLP on 12/4/2023

Recent Nuclear Verdicts Highlight Danger of Punitive Damages - In October and November 2023, four separate products liability trials ended with large plaintiff verdicts. Three of these verdicts were against Monsanto in...more

Timeline: Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence

Akin Gump Strauss Hauer & Feld LLP on 11/13/2023

On October 30, 2023, the Biden administration issued its long-awaited artificial intelligence (AI) executive order (EO), which issues directives to over 20 federal agencies, with the deadline for implementation spanning...more

Crypto Regulation in Europe: ESMA Statement Clarifies process for the Transition to MiCA

Goodwin on 10/25/2023

On 17 October 2023, the European Securities and Markets Authority (ESMA) published a statement (the Statement) clarifying the timeline for implementation of the Regulation on Markets in Cryptoassets ((EU) 2023/1114) (MiCA)...more

Antitrust & Competition Life Sciences Quarterly Update - Q3 2023

Goodwin on 10/24/2023

The FTC’s Amgen/Horizon Lawsuit Ends With a Whimper - We covered the FTC’s investigation into (and litigation challenging) Amgen’s $28.3 billion acquisition of rare disease specialist Horizon Therapeutics in our Q1 and...more

FDA finalizes advice on cybersecurity info to include in device submissions

Hogan Lovells on 10/4/2023

The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which advises medical device manufacturers on...more

[Webinar] FDA Tries to Keep Up: How FDA and Industry Are Trying to Keep Up With Artificial Intelligence - September 13th, 2:00 pm...

Arnall Golden Gregory LLP on 9/6/2023

FDA has cleared or approved hundreds of products that work with artificial intelligence (“AI”) and acknowledges that the agency and industry need help navigating how FDA-regulated products engage with AI. In response to the...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

FDA Issues First Guidance on Clinical Trials for Psychedelic Drugs

Holland & Knight LLP on 6/27/2023

The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design and desired features of clinical trials for psychedelic drugs LSD and MDMA There has been growing...more

The Evolving FDA Regulatory Landscape of Artificial Intelligence

Gardner Law on 3/29/2023

As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more

New FDA electronic records guidance prioritizes Digital Health Technology oversight

Hogan Lovells on 3/28/2023

On March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for...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

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on 8/17/2022

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

CPRA Draft Regulations Issued

Husch Blackwell LLP on 5/31/2022

Keypoint: The California Privacy Protection Agency issued a first set of draft regulations that contain a number of notable provisions but do not address all of the CPRA’s rulemaking topics....more

FDA Issues Draft Guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

King & Spalding on 5/9/2022

On April 8, 2022, FDA issued new, long-awaited draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (Draft Cybersecurity Guidance). 1 This draft guidance...more

FDA issues ambitious new draft guidance to promote clinical trial diversity

Hogan Lovells on 4/18/2022

On April 14, the U.S. Food and Drug Administration (FDA) released a new draft guidance to industry for increasing racial and ethnic diversity in clinical trials. The draft guidance, “Diversity Plans to Improve Enrollment of...more

FDA updates “cybersecurity in medical devices” guidance, seeks industry input - Draft guidance addresses quality system...

Hogan Lovells on 4/15/2022

The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which aims to help industry take a more...more

ICO consults on new guidance for conducting scientific research under the UK GDPR

Hogan Lovells on 3/2/2022

Research and development, innovation, product and service improvement, AI design and deployment...these are key commercial drivers for the successful modern business. They also underpin technological, medicinal, and other...more

Alston & Bird Health Care Week in Review - February 2022 #2

Alston & Bird on 2/15/2022

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

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