Daily Compliance News: July 22, 2025, The I-9 Hell Edition
FCPA Compliance Report: Ethical Challenges in AI, Data Protection, and Sports with Andre Paris
Compliance into the Weeds: Boeing’s New Safety Initiatives and Compliance Reforms
Great Women in Compliance – Compliance is the Floor, Ethics is the Ceiling with Ellen Hunt
Great Women in Compliance: Creating Space to Speak Up: The Story Behind Psst.org
Hidden Fees in the Live-Event Ticketing and Short-Term Lodging Industries
Digital Planning Podcast Episode: Estate Planning and the Corporate Transparency Act
Episode 330 – Halyna Senyk on Anti-Corruption Progress in Ukraine
ESG Masterclass — ESG and Impact Investing
FCPA Compliance Report – Jonathan Wilson on The NSBU Decision
Áine Bryn of Mercer UK on Demonstrating the Strategic Credibility of the Marketing Function - Passle's CMO Series Podcast
Podcast - The CFPB's Proposal to Create a Public Registry
Breaking Mindsets with Sharon Sorkin from Ford on Being Reliably Transparent
Auditing and Monitoring in Healthcare
Exploring The ‘S’ In ESG & What To Expect In 2023
The Line Between Gift Giving and Bribery
The New Cold War: Risk, Sanctions, Compliance Episode 21: "Interview with Drago Kos of the OECD Working Group on Bribery"
ABA Sound Advice: Conducting Civil Rights Audits: Benefits and Best Practices
Early Advocates of Organic Food Products, Amy’s Kitchen Believes in the Benefits of a Fully Regenerative Ecosystem and Aims to Help Heal the Planet Through Its Business
Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally...more
On July 9, 2025, the U.S. Food and Drug Administration (FDA) issued a letter from Commissioner for Human Foods Martin Makary and Deputy Commissioner for Human Foods Kyle Diamantas to industry members involved in the...more
On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more
On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more
This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...more
On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced publication of over 200 complete response letters (CRLs) issued in response to applications submitted to FDA for approval of drugs or biologics between...more
On June 18, the US Food and Drug Administration (FDA) released for public comment a proposed method for ranking chemicals present in the food supply to determine which should be prioritized for post-market safety assessments....more
Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to potential impacts on patient safety, healthcare quality, bias mitigation, and public trust. To...more
In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more
On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more
Through an Order that the Secretary of the U.S. Department of Health and Human Services (HHS) Robert F. Kennedy Jr. (RFK) called an act of “radical transparency,” the U.S. Food and Drug Administration (FDA) has been directed...more
United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing...more
Public Health - Withdrawing from the World Health Organization (WHO)...more
In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...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
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...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 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
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more
The rapid advancement of Artificial Intelligence (AI) and Machine Learning (ML) is revolutionizing the healthcare industry. However, as these innovative devices emerge, understanding the complex regulatory landscape becomes...more
Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more
The FDA is strengthening its oversight of food chemicals, signaling a shift towards a more proactive and comprehensive approach to food safety. This move comes in the wake of increasing public concern over the long-term...more
Congress returned to Washington this week with just five weeks left in this year’s legislative calendar. With a Continuing Resolution (CR) that expires December 20, 2024, either a year-end spending package or a new Continuing...more