Demystifying Wage and Hour Audits: One-on-One with Courtney McFate
Compliance Tip of the Day: Finance Models for Compliance
Compliance Tip of the Day - Extending Compliance Value Across Your Organization
Compliance Tip of the Day: Design - Centric Internal Controls
Hospice Insights Podcast - Hospice Audit Updates: Hospices Fare Well in Federal Court
Compliance Tip of the Day: Internal Control Improvement
Compliance Tip of the Day: Assessing Internal Controls
Compliance Tip of the Day: COSO Objective 5 – Monitoring Activities
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
Compliance Tip of the Day: COSO Objective 3 – Control Activities
FCPA Compliance Report: Fraud Risk Management - Insights and Experiences with Peter Schablik
Hot Topics in International Trade - Let's Be Serious-Supply Chain Audits
Workplace ICE Raids Are Surging—Here’s How Employers Can Prepare - #WorkforceWednesday® - Employment Law This Week®
REFRESH Five Tax Traps for Business Lawyers Advising Nonprofit Organizations
Hospice Insights Podcast - Hospice Audit Updates: David Beats Goliath
Compliance Tip of the Day: Middle Managers as the Eyes and Ears of Compliance
Episode 365 -- Four Sanctions Cases Everyone Should Know
UPIC Audits
Compliance Tip of the Day: The role of Compliance in Auditing AI
California Employment News: Taking Advantage of the PAGA Reform – How Employers Can Lower Their Risk of PAGA Liability
As the manufacturing sector continues to navigate a dynamic economic and regulatory landscape, the current environment presents both significant opportunities and complex challenges. From strong buyer demand in a competitive...more
The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more
It is expected that the next few years will be a challenging time for manufacturers in Mexico, with the automotive industry being particularly vulnerable as multiple pressure points come to a head: (1) the United...more
Over the last five years, auto and equipment dealers experienced a period of low inventory levels with high margins on the limited inventory they had for sale and lease. Used automotive and equipment wholesale and retail...more
On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...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
“Per- and Polyfluoroalkyl Substances” (“PFAS”) are a group of approximately 15,000 chemicals found in thousands of products ranging from consumer products like food packaging, non-stick cooking materials, and cosmetics to...more
The automotive industry continues to grow a record of sustainability, improving fuel efficiency and proliferating electric vehicles, and adopting eco-friendly manufacturing processes. Along with these important sustainability...more
The title of CMS’s May 26 proposed rule, “Misclassification of Drugs, Program Administration and Program Integrity Updates Under the MDRP,” buries the lede. Amid twenty Medicaid Drug Rebate Program-related proposals—some...more
Please join us for the fourth episode of Wiley’s Federal Infrastructure Webinar series, a series of webinars that will bring together attorneys from across the firm to discuss current developments relating to the federal...more
Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are dominating the environmental health news cycles based on numerous studies which demonstrate their potential risks. The U.S. Environmental Protection Agency (EPA) is...more
As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more
In late December 2021, the United States banned imports of disposable gloves produced in Malaysia by manufacturer Brightway Holdings over allegations of forced labor....more
State legislatures across the country spent the first half of 2021 enacting laws that include several changes to warranty reimbursement obligations owed by suppliers to authorized dealers. Four states have new warranty...more
Since the November presidential election, most trade journals have expressed the same or similar headlines: “The Joe Biden/Kamala Harris administration will elevate enforcement for violation of environmental rules and...more
Equipment manufacturers are generally well aware of the onerous and often expensive equipment repurchase obligations they incur when terminating or non-renewing a dealer. But at least these repurchase obligations make some...more
A few weeks ago, AGG’s Food and Drug Practice Team launched its podcast series to discuss topics affecting the FDA-regulated industry. The series, called “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues,”...more
The TSCA Chemical Data Reporting requirement is an important mechanism that helps EPA establish regulatory restrictions and enforcement initiatives. The next filing deadline is November 30, 2020 and requires the submission...more
Amidst a flurry of policymaking from the White House last week, President Trump issued the Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States on August...more
The CARES Act includes significant measures for individuals, employers, and businesses to handle and overcome the COVID-19 pandemic. The set of FAQs below is intended to address questions related to the potential risk of...more
Over the past several months, the Health Resources and Services Administration (HRSA) has issued a number of guidance updates related to the agency's expectations for health care providers participating in the 340B drug...more
OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more
This article is the first entry in a multi-part series on the critical need for businesses to extract total value from their IP assets by developing and applying a comprehensive, consistent and efficient IP strategy. An...more
Apple has filed its Form SD for the year ended December 31, 2015. It includes this disclosure: The combination of training, public reporting and a ticking clock drove the number from 82 smelters and refiners...more
On January 11thth, I put up my last post stating that because of its length, I have broken up the post into two parts. This February post includes a Trade, Customs and IP update with longer sections on Antitrust and...more