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 October 2, 2024, the U.S. Food and Drug Administration (FDA) released guidance in a question and answer format regarding the use of electronic systems, electronic records, and electronic signatures in clinical...more
On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more
On September 24th and 25th, the National Institute of Standards and Technology (NIST) convened a symposium to generate new insights about the next steps needed to unleash AI innovations that will enable trust in this...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
The enforcement trends of 2023 have continued into 2024, especially with respect to the U.S. Consumer Product Safety Commission (CPSC or Commission) and the U.S. Food and Drug Administration (FDA or Agency). Both have ramped...more
Even the best company is not perfect. Mix ups, mathematical errors, transposing numbers, forgetting to sign a batch production, a supplier mix-up, or any one of an almost infinite potential glitches in the very complex...more
In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best...more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
Proving access to and use of trade secrets are core elements in a trade secrets misappropriation case. Recent rulings in a trade secrets action filed by Allergan against its competitor Revance Therapeutics (“Revance”)...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 30, 2023, the Biden Administration released and signed an Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (Executive Order) that articulates White House...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
When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...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
In the waning days of 2022, FDA issued an updated Food Code with several important updates. FDA is responsible for more than a quarter of the U.S. economy, and the Food Code impacts virtually every American. Originally...more
Without a clear social media policy, a business runs the risk of harming its brand and running afoul of regulatory guidelines which limit corporate speech or require certain disclosures. Employees and officers of the company...more
For the first time since the passage of the Food, Drug and Cosmetic Act in 1938, the Federal cosmetics law has been substantially updated with the passage of the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”)....more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed by the U.S. Congress as part of the omnibus Consolidated Appropriations Act enacted on December 29, 2022 and will grant the U.S. Food and Drug...more
We are pleased to present our annual End of Year Plan Sponsor “To Do” Lists. This year, we present our “To Do” Lists in four separate Employee Benefits Updates. This Part 1 covers year-end health and welfare plan issues....more
The US Food and Drug Administration (FDA) published its Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff (final guidance) on March 4, 2022. The final guidance describes how...more
The ABA Washington Health Law Summit is the premier legal conference focusing on health law policy and, as a result, offers insight into current and future major policy issues. But, as always at this conference, there are...more