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 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 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
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
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
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
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
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
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...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
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
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
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more