Podcast - Regulating AI in Healthcare: The Road Ahead
AI and the False Claims Act
Key Discovery Points: Detecting AI is Difficult and Tricky!
[LEGAL MARKETING MOMENTS] A Simple Tip to Master Generative AI Prompts
The Briefing: The Wrong Argument – Why Authors Lost Against Meta and What Comes Next
Lawyers Beware: There Could Be Serious Ethics Issues With The New AI Browsers
From OCR to AI The Future of Media and Image Analysis in eDiscovery
LathamTECH in Focus: Navigating National Security: The Impact of FDI Reviews on Tech M&A
Podcast - Tips for Maintaining FTC Compliance When Using AI
Compliance Tip of the Day: Rethinking Corporate AI Governance Through Design Intelligence
Julie Mortimer of Mills & Reeve on The Right Way to Kickstart Your CRM Strategy - Passle's CMO Series Podcast EP176
Law School Toolbox Podcast Episode 513: Grappling with AI as a Law Student and Lawyer (1L Summer Series)
The Briefing: Anthropic, Copyright, and the Fair Use Divide
SkadBytes Podcast | Tech’s Shifting Landscape: Five Trends Shaping the Conversation
Hospice Insights Podcast - AI in Action: Exploring How AI Is Helping Hospices Do Things in New Ways
How to Rank in the Age of AI Search: On Record PR
AI in eDiscovery Today: An Open Conversation
Innovation in Compliance: Allison Lagosh on Proactive Compliance Planning for Regulatory Changes
FCPA Compliance Report: Ethical Challenges in AI, Data Protection, and Sports with Andre Paris
Work This Way: An Employment Law Video Podcast | Episode 51: Smarter Recruiting Strategies with Rhiannon Poore of Forge Search
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more
The US Food and Drug Administration (FDA) launched Elsa, a generative artificial intelligence (AI) tool designed to assist FDA employees with tasks such as reading, writing, and summarizing. The press release on the tool’s...more
In April 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance titled “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” outlining its commitment to advancing New Approach...more
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
The FDA began integration of generative AI across all its centers, a project that should be completed by the end of June. Newly appointed chief AI officer, Jeremy Walsh, and Office of Strategic Programs at CDER, Sridhar...more
The U.S. Food and Drug Administration (FDA) has introduced “Elsa,” a generative AI tool designed to enhance the efficiency of its regulatory operations. Elsa's deployment comes nearly a month ahead of the agency’s original...more
Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more
The FDA is moving quickly to bring artificial intelligence (AI) into the heart of its regulatory review process. On May 8, 2025, the agency announced the successful completion of its first AI-assisted scientific review—and...more
The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more
Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more
On May 8, 2025, the Food and Drug Administration (FDA) announced the completion of its generative artificial intelligence (AI) pilot program for scientific reviewers. FDA Commissioner Marty Makary was quoted in the...more
If the initiative proceeds as planned, it will mark a pivotal shift in the regulatory landscape, introducing both efficiencies and novel questions related to the reliability and validity of the AI reviews, as well as...more
To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more
On April 10, 2025, the US Food and Drug Administration (FDA) announced its intent to phase out the use of animal testing in the development of certain drugs and biologics. To help bring this “paradigm shift in drug...more
The U.S. Food and Drug Administration (FDA) recently announced it plans to phase out animal testing in the development of monoclonal antibody therapies and other drugs and biological products “with more effective,...more
In this episode of Holland & Knight's "The Eyes on Washington" podcast series, attorneys Rachel Gartner, Sara Klock, John Vaughan and Michael Werner discuss the evolving landscape of U.S. Food and Drug Administration (FDA)...more
Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics. For pharmaceutical and medical device companies, AI-driven solutions present...more
News Briefs - Hospital, Device Makers Seeking Exemptions on Tariffs - Medical device makers, hospitals, and other key health industries are pressing to gain exemptions under the Trump administration's new tariff regime with...more
Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more
Dr. Jayanta (Jay) Bhattacharya, nominated to be Director of the National Institutes of Health (NIH), and Dr. Martin Makary, nominated to be the Commissioner of the U.S. Food and Drug Administration (FDA), appeared before the...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
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more