Your Guide to Dealing with Subpoenas Effectively
The Future of Supply Chains: Chris Andrassy on Using AI to Predict & Prevent Disruptions
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Podcast: Addressing Patient Complaints About Privacy Violations
London Partner Roberta Downey Wired for Disputes: Tech, Infrastructure, and the New Frontier of Risk
Compliance Amidst a Global Consensus Breakdown
Safeguarding Your Business Data
(Podcast) The Briefing: When a TikTok Costs You $150,000 - Copyright Pitfalls in Influencer Marketing
New Executive Order Targets Disparate Impact Claims Nationwide - #WorkforceWednesday® - Employment Law This Week®
Compliance into the Weeds: Of Wal-Mart, Tariffs and Stakeholder Capitalism
Daily Compliance News: May 21, 2025, The I Want You Back Edition
Hot Topics in International Trade Terrified by Tariffs Braumiller Law
Tariffs and Trade Series: What Boards of Directors Need to Know
False Claims Act Insights - How Payment Suspensions Can Impact FCA Litigation
Harnessing AI in Litigation: Techniques, Opportunities, and Risks – Speaking of Litigation Video Podcast
Upping Your Game: Episode 3 - Embedded Compliance: From Gatekeeper to Business Enabler
Strategies for Business Resilience in Uncertain Times
Innovation in Compliance: Staying the Course in Compliance: Insights from Kristy Grant-Hart
Daily Compliance News: May 20, 2025, The What Could Go Wrong Edition
Compliance Tip of the Day: Design Objectives for Compliance Training
On February 6, 2025, the European Union (EU) Advocate General (EU AG) recommended that the European Court of Justice (ECJ) overturn the 2022 decision of the General Court annulling the 2019 harmonized classification and...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software...more
Following consultation starting in 2022, on November 29, 2024, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) were registered. These Regulations amend the Food and Drug...more
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
Michael Ostheimer, a senior staff attorney for the Federal Trade Commission (FTC), joined Holland & Knight for a recent webinar presentation on social media advertising and marketing practices. This Holland & Knight alert...more
The Food and Drug Administration (FDA) released a statement yesterday explaining its conclusion that a new regulatory pathway is needed to allow for greater oversight and to better manage risks associated with cannabidiol...more
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
Like every aspect of our society, the coronavirus is affecting class action litigation. In the last month a rush of new “corona” class actions have been filed, and businesses are seeing novel class claims. The headlines have...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more
Hogan Lovells Total Brand Care is our firmwide holistic approach to creating, commercializing and protecting our clients’ most valuable asset – their brands. Creative product labeling and packaging can help promote and add...more
From bright and glossy, to refined and elegant, product labeling and packaging convey information, messaging, and claims about a brand. At the same time the labeling and packaging must also include mandatory information,...more
On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more
The Food and Drug Administration (FDA) issued guidance yesterday (September 6, 2017) entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices,” which is intended to “assist...more
The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...more