Compliance Tip of the Day: Trust and Verify
Great Woman in Compliance: Building Strategic and Effective Risk Assessments
Compliance into the Weeds: The Dark Side of AI in Employee Training
Compliance Tip of the Day: AI Assistant for Compliance
Innovation in Compliance: Gaurav Kapoor on Risk Management and the Role of AI in GRC
How to Balance Diverse Views in the Office
Compliance Tip of the Day: Costs and Benefits of AI
Adventure in Compliance: The Novels - The Valley of Fear, Whistleblowers and Corporate Compliance
Sunday Book Review: August 17, 2025, The More Books from the Ethicsverse Library Edition
Compliance Tip of the Day: How a CFO Views Compliance and Risk
Data Driven Compliance – James Tillen on the Importance of Cross-Functional Collaboration in Complying with the FTPF Offense
We get Privacy for work — Episode 7: What Is a WISP and Why Your Organization Must Have One
Great Women in Compliance: The Mind at Work with Lynette Buebird
Compliance Tip of the Day: Finance Models for Compliance
Compliance Tip of the Day - Extending Compliance Value Across Your Organization
Adventures in Compliance: The Novels - The Valley of Fear, Sherlock Holmes’ Investigative Techniques for Today’s Challenges
Creativity and Compliance: Reinventing Compliance with Creativity: The Acteon I-Care Code
Data Driven Compliance: Understanding the ECCTA and Its Impact with Jonathan Armstrong
AI and the False Claims Act
Compliance Tip of the Day: AI and 3rd Party Risk Management
In the FDA-regulated industry, a compliance program isn’t just a formality—it’s a critical tool for protecting your business, patients, and reputation. Still, too many companies treat compliance policies as static...more
The Hatch-Waxman Act regulates the relationship between branded and generic drugmakers and attempts to strike a balance between two competing policy interests — encouraging pioneering drug development and facilitating market...more
In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more
On November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its anticipated General Compliance Program Guidance (“GCPG”) for the health care industry. The GCPG serves as a...more
On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more
Food - FDA Extended Comment Period for Rule on Food Standards – The comment period on the proposed rule was extended until July 20. The proposed rule, “Food Standards; General Principles and Food Standards Modernization,”...more
U.S. and international health authorities continue to respond to the outbreak of the novel coronavirus (COVID-19). While originally detected in Wuhan City, Hubei Province, China, as of the date of this alert the virus has now...more
On Jan. 15, 2019, Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks issued a statement proposing policies to support cell and gene...more
On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet high-quality standards. Currently, there are over 5,000...more
In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of approval or clearance. Only 33...more
As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more