Compliance Tip of the Day: Rethinking Corporate AI Governance Through Design Intelligence
Compliance Tip of the Day: COSO Governance Framework: Part 4, Culture
Compliance Tip of the Day: COSO Governance Framework: Part 1, Introduction
Compliance Tip of the Day: Internal Control Deficiencies
FCPA Compliance Report: Stay the Course: Ellen Lafferty on Navigating Anti-Corruption Compliance in 2025
Adventures in Compliance: The Novels – The Hound of the Baskervilles, Introduction and Compliance Lessons Learned
Compliance Tip of the Day: Assessing Internal Controls
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Compliance Tip of the Day: COSO Objective 5 – Monitoring Activities
Compliance Tip of the Day: COSO Objective 4 - Control Information and Communication
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
Compliance Tip of the Day: COSO Objective 3 – Control Activities
Compliance Tip of the Day – COSO Objective 1 – Control Environment
Compliance Tip of the Day: Code of Conduct as an Internal Control
Rethinking Records Retention
Compliance Tip of the Day: Internal Controls for GTE
FCPA Compliance Report: Revolutionizing Speak Up: Ariel D. Weindling on Enhancing Whistleblower Systems
Compliance Tip of the Day: Implementing Internal Controls
Podcast: Addressing Patient Complaints About Privacy Violations
Compliance Amidst a Global Consensus Breakdown
Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more
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
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On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to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
First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” the idea of a defined set of...more
On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan...more
How will the election affect life sciences in 2021 and beyond? What’s ahead for the regulatory and policy environment? In this session, our elite group of policy analysts reviewed the election results and the far-reaching...more
As the COVID-19 pandemic continues to alter ways of life across the globe, clinical trials must be adapted for participant safety while maintaining accuracy in the midst of the ongoing crisis. In September 2020, the U.S. Food...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
As part of its effort to address the shortage of medical equipment needed to address the COVID-19 pandemic, FDA has issued a new Enforcement Policy announcing flexibility in some of the regulatory requirements for...more
As healthcare providers and universities respond to the spread of COVID-19, legal counsel at these institutions should be prepared to assist their institution’s research enterprise in anticipating and reacting to any changes...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
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
The cybersecurity ramifications of the Internet of Things (IoT) are perhaps nowhere more crucial—potentially a matter of life and death, in fact—than in the realm of medical devices. Until recent times, a potential hack of...more