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Cannabis Law Now Podcast - The 4-1-1 on Cannabis Receiverships from a Top Cannabis Receiver
The LathamTECH Podcast — Where Digital Assets Slot Into a Shifting Fintech Regulatory Landscape: Insights From the US, UK, and EU
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New Executive Order Targets Disparate Impact Claims Nationwide - #WorkforceWednesday® - Employment Law This Week®
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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
On April 14 2025, the European Data Protection Board (EDPB) announced the outcomes of its plenary session that took place on April 8 2025, during which the EDPB adopted draft Guidelines on processing of personal data through...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The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025.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The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more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
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
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more
Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more
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
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...more
On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more
In this month's edition of our Privacy & Cybersecurity Update, we take a look at guidance on artificial intelligence released by the U.K. Information Commissioner's Office and the Turing Institute, as well as guidance...more