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
A Massachusetts federal court recently granted summary judgment in favor of a motorcycle manufacturer and dismissed claims by a dealer who argued the manufacturer’s internet sales policy breached the dealer agreement between...more
As federal agencies and states grapple with regulating artificial intelligence (AI) to enhance its safety profile, and as businesses race to adopt AI for myriad purposes, it is important to recognize a general safety...more
Welcome to this edition of the FP Snapshot on Manufacturing, where we take a quick look at a significant workplace law issues that can impact manufacturers. This edition will focus on workplace investigations and how...more
Smart hiring often includes a post-offer criminal background check on the job candidate to help employers make informed decisions. This practice can reveal potential employment risks like theft, workplace violence, or...more
Recent U.S. developments indicate a growing focus on regulating and investigating the data privacy practices of companies in the automotive sector. The Federal Trade Commission (FTC) recently highlighted in a blog post its...more
The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more
Did you know that the United States currently has over 2 million Drug Enforcement Administration (DEA) registrants engaging in activities with controlled substances? Whether you’re a student in residency, a healthcare...more
Drug and device manufacturers doing business in Nevada have upcoming filing deadlines in March, April, and June. By June 1, 2024, compliance officers must sign and submit a certification to the Nevada Board of Pharmacy to...more
The Pregnant Workers Fairness Act (PWFA) went into effect on June 27, 2023. The Equal Employment Opportunity Commission (EEOC) must issue final regulations to implement the PWFA by Dec. 29, 2023. This article summarizes key...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
To help protect against criminal ransomware and cyberattacks, modern manufacturing plants should ensure they have reasonable physical, administrative, and technical safeguards in place....more
On January 30, the U.S. Court of Appeals for the Third Circuit issued a unanimous decision in favor of drug manufacturers, finding that manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing...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
Like many other industries, manufacturing has been hit hard with labor shortages. As of April 2022, U.S. factory activity reportedly is at its slowest pace in more than 18 months. Consequently, many factories seek more...more
2021 was a game-changing year in cybersecurity. There were many high profile vulnerabilities and data breaches, and responses from the government and private sector. A few examples include Accellion, SolarWinds, Microsoft...more
The Centers for Medicare & Medicaid Services (CMS) calendar year 2022 rule finalizing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Final Rule) was published on November 19, 2021....more
Many manufacturing companies are beginning to envision what the workplace will look like in the near future. While some manufacturing work cannot be done remotely because it is impossible or impractical, many companies were...more
On June 4, 2020, the Kansas Legislature passed the COVID-19 Response and Reopening for Business Liability Protection Act. It now goes to Governor Laura Kelly for signature....more
Covid-19 has caused serious disruption to manufacturers’ ability to produce products and fill orders on a timely basis, which in turn has impeded the performance of countless supply chains....more
The patchwork of federal, state and local laws addressing leaves of absence, protections of people with disabilities and a manufacturer’s general obligation to provide a safe workplace come head-to-head with public reports of...more
At the end of December, China acknowledged the existence of the coronavirus, and this burgeoning heath crisis is becoming a supply chain problem. China, a major manufacturing hub for materials, products and components being...more
Now in its third month, the coronavirus outbreak that began in Wuhan, China, has claimed over 2,000 lives and brought one of the world’s most dynamic economies to a near standstill. ...more
Welcome to 2020! As always, we at the Manufacturing Law Blog are starting the year with our annual forecasts of hot topics....more
Seyfarth Synopsis: OSHA recently updated its National Emphasis Program on Amputations in Manufacturing Industries (NEP), adding a targeting methodology for industries with high employer-reported amputation statistics....more