Upping Your Game: Episode 1 – Meeting Hui Chen’s Challenge
SBR – Author’s Podcast: Understanding Complexity with Dr. Jean Boulton, Part 1: Ethics, Compliance, and Organizational Dynamics
Innovation in Compliance: Exploring the Fractional COO Model with La Tonya Roberts
Daily Compliance News: April 29, 2025, The GenZ/RTO Edition
Adventures in Compliance: The Novels – A Study in Scarlet, Introduction to Compliance Lessons
FCPA Compliance Report: From Compliance to Commercial Value: Removing Friction with AI
Compliance Tip Of the Day: Using AI to Transform Whistleblower Response
Because That’s What Heroes Do: Deep Space 9 – Episode 30: Deep Trek Themes from Tacking into the Wind
Compliance Tip of the Day: The Future of Continuous Monitoring
FCPA Compliance Report: Ellen Hunt on Compliance ROI and on a Due Diligence and the US Sentencing Guidelines
Compliance and AI: Transforming Compliance Through AI with Marcelo Erthal
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
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The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.”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the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more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 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 October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on designing...more
Seyfarth Synopsis: In compliance with the New York State Anti-Sexual Harassment legislation passed earlier this year, the Office of Governor Andrew M. Cuomo has released drafts of the model sexual harassment policy, training...more
The State of New York recently issued draft guidance for employers regarding the anti-sexual harassment legislation passed earlier this year....more