Driven by Data: Auto Finance Trends Uncovered - Moving the Metal: The Auto Finance Podcast
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Mistakes Lawyers Should Avoid When Moving into Compliance
Beyond the Bylaws: The Medical Staff Show | The Role of Bylaws in Medical Staff Governance, Part II
Compliance Tip of the Day – AI and Behavioral Analytics
Daily Compliance News: April 30, 2025, The 4 AM Wake-Up Call Edition
Regulatory Ramblings: Episode 68 - Why Geopolitical Risk Matters to Compliance and Legal Staff with Mark Nuttal and Chad Olsen
Key Discovery Points: Don’t Rush in as an AI Fool!
Upping Your Game: Episode 1 – Meeting Hui Chen’s Challenge
SBR – Author’s Podcast: Understanding Complexity with Dr. Jean Boulton, Part 1: Ethics, Compliance, and Organizational Dynamics
Innovation in Compliance: Exploring the Fractional COO Model with La Tonya Roberts
Daily Compliance News: April 29, 2025, The GenZ/RTO Edition
Adventures in Compliance: The Novels – A Study in Scarlet, Introduction to Compliance Lessons
FCPA Compliance Report: From Compliance to Commercial Value: Removing Friction with AI
Compliance Tip Of the Day: Using AI to Transform Whistleblower Response
Because That’s What Heroes Do: Deep Space 9 – Episode 30: Deep Trek Themes from Tacking into the Wind
Compliance Tip of the Day: The Future of Continuous Monitoring
FCPA Compliance Report: Ellen Hunt on Compliance ROI and on a Due Diligence and the US Sentencing Guidelines
Compliance and AI: Transforming Compliance Through AI with Marcelo Erthal
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
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Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more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