AI Today in 5: August 7, 2025. The US v. China Episode
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 245: Using AI to Improve Radiology with Angela Adams of Inflo Health
AI Today in 5: August 5, 2025, The AI at the SEC Episode
Compliance Tip of the Day: AI, Whistleblowing and a Culture of Speak Up
Podcast - Regulating AI in Healthcare: The Road Ahead
AI and the False Claims Act
Innovation in Compliance: The Future of Compliance Training: AI, Adaptive, Learning, and Cultural
Compliance Tip of the Day: AI, Continuous Monitoring and Compliance
Key Discovery Points: Detecting AI is Difficult and Tricky!
Compliance Tip of the Day: AI and 3rd Party Risk Management
Compliance Tip of the Day: Bringing Predictive Analytics into Your Compliance Regime
(Podcast) The Briefing: The Wrong Argument – Why Authors Lost Against Meta and What Comes Next
The Briefing: The Wrong Argument – Why Authors Lost Against Meta and What Comes Next
Compliance and AI: Navigating Risk Management in the AI Era with Gaurav Kapoor
From OCR to AI The Future of Media and Image Analysis in eDiscovery
(Podcast) The Briefing: Anthropic, Copyright, and the Fair Use Divide
Hospice Insights Podcast - AI in Action: Exploring How AI Is Helping Hospices Do Things in New Ways
AI in eDiscovery Today: An Open Conversation
The Authenticity Advantage: How Runbin Dong’s Scale Social AI Helps Small Businesses Shine
Podcast - FTC to Focus on Deceptive AI Claims: Compliance Management Strategies
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
In April 2025, McDermott once again hosted its annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more
The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change...more
Our 2025 Life Sciences and Health Care Horizons edition is now live! Explore the latest global insights from the U.S., Asia-Pacific, Europe, Latin America, and the Middle East on the key issues and emerging trends shaping the...more
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will be phasing out the current requirements for animal testing in the development of monoclonal antibody therapies and other drugs, replacing them...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
In 2024, not one but two Nobel Prizes (in Chemistry and Physics) were awarded to researchers for their work in artificial intelligence ("AI"). Particularly noteworthy for the life science community is the Nobel Prize in...more
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....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 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
Since 1995, Nature Medicine has been chronicling advances in medical technology and health care. To mark the journal’s 30th anniversary, each month an issue of critical importance for the future of medicine will be...more
Artificial intelligence already is positively affecting health, according to Mark Gardner, MBA, Esq., Founder and Managing Partner, Gardner Law, which represents clients subject to Food and Drug Administration regulations....more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more
The U.S. Food and Drug Administration (FDA) recently published its long-awaited draft guidance on considerations for the use of artificial intelligence (AI) to support regulatory decision-making for drug and biologics, which...more
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more
The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A)....more
The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality. The agency noted an...more
FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration's ("FDA" or "Agency")...more
As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more
The scientific benefits and legal risks of AI-driven drug discovery are consequential. But recent IP law decisions allude to a general concept that IP rights will not be awarded if AI completely or significantly replaces...more
Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an artificial...more
For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more
Last week, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials published a “Special Communication” in JAMA titled, “FDA Perspective on the Regulation of Artificial...more