Because That’s What Heroes Do: Deep Space 9 – Episode 30: Deep Trek Themes from Tacking into the Wind
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Compliance Tip of the Day: Leveraging AI for Real-Time Third-Party Risk Management
FCPA Compliance Report: Amanda Carty on a Due Diligence and Risk Management
Innovation in Compliance: Design-Centric Compliance Training with Karen Oddo
Compliance Tip of the Day: AI and Predictive Analytics
FCPA Compliance Report: Kristy Grant-Hart on A 360° Review of the Future of Compliance
Great Women in Compliance: Creating Space to Speak Up: The Story Behind Psst.org
Daily Compliance News: April 23, 2025, The R-E-S-P-E-C-T Edition
Aligning Business Goals with Legal Strategies Amid Regulatory Change – Speaking of Litigation Video Podcast
Compliance Tip of the Day: Embedded Compliance
AI in Employment: Navigating the Legal Landscape with Lessons from I, Robot — The Good Bot Podcast
Innovation in Compliance: Strategic Compliance in Regulated Industries with Kerri Reuter
Daily Compliance News: April 22, 2025, The Upping Your Game Edition
Insider Strategies for Wage and Hour Compliance Success: One-on-One with Paul DeCamp
Compliance Tip of the Day: The Role of Supply Chain and Compliance in Tariffs
Innovation in Compliance: The Strength Trap: When Being the Strong One Starts Breaking You – Part 3: Mastering Stress Communication with the C.A.R.E.S. Framework
Daily Compliance News: April 17, 2025, The Musk Fights BEE's Edition
Daily Compliance News: April 16, 2025, The Fired by AI Edition
Compliance Tip of the Day: Role of Compliance in Upcoming Trade Wars
2025 is set to be a busy year in UK consumer protection law. With the CMA issuing its annual plan for 2025 / 2026 on 27 March 2025 and its new powers to enforce consumer protection law under the Digital Markets, Competition...more
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more
The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more
Over the last few years, the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more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 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
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 6, the U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance regarding Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a...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
The Department of Commerce released three final guidance documents incorporating public comments from earlier this spring which provide recommendations for managing AI risk, securing AI software development processes, and...more
Welcome to the April-May edition of Akin Intelligence. This edition is a double header, covering both months as we prepare for the launch of our new AI Hub—a one-stop resource for AI coverage that will launch soon. Starting...more
The U.S. National Institute of Standards and Technology (NIST) is seeking comment on four draft publications meant to promote safe, secure, and trustworthy artificial intelligence (AI) systems. Two drafts provide guidance to...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more
Welcome to this week's issue of AI: The Washington Report, a joint undertaking of Mintz and its government affairs affiliate, ML Strategies. The accelerating advances in artificial intelligence (“AI”) and the practical,...more
Seyfarth Synopsis: Following President Biden’s comprehensive Executive Order on AI, the White House announced the formation of the “US AI Safety Institute” within the Commerce Department’s technology arm, the NIST. The...more