On June 20, six federal financial services regulators issued the final automated valuation model (AVM) rule. The AVM rule, initially proposed in June 2023 and discussed here, aims to implement the quality control standards...more
The Public Company Accounting Oversight Board (PCAOB) expanded its enforcement activity to the highest level since 2017, according to a new report released today by Cornerstone Research. Monetary penalties imposed by the...more
In the ever-expanding landscape of e-commerce, the presence of unauthorized resellers can pose significant threats to a brand’s reputation and bottom line. Brands should take a proactive approach in combatting unauthorized...more
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information for drug companies and...more
Almost daily, the power of generative artificial intelligence (genAI) reveals itself through new use cases, applications, and platforms. No one can argue that this technology is here to stay and the impact on speed and...more
The proposed rule, if adopted, would apply to mortgage originators and issuers of mortgage-backed securitizations that rely on automated valuation models (“AVMs”) to determine the value of real estate collateral. The...more
Mortgage originators and secondary market issuers use automated valuation models (AVMs) in determining the worth of collateral securing mortgages on consumers’ principal dwellings. As part of the Dodd-Frank Wall Street Reform...more
Unauthorized Sellers are a growing and ubiquitous problem for brands selling their goods on eCommerce marketplaces, such as Amazon, eBay, and Walmart. Unauthorized resellers sell products without the brand’s authorization or...more
In the rapidly evolving world of artificial intelligence (AI), one development stands out for its transformative potential: the rise of generative AI tools. Many major technology companies are building the large language...more
On June 21, 2023, the Office of the Comptroller of the Currency (OCC), Treasury, Board of Governors of the Federal Reserve System (Board), Federal Deposit Insurance Corporation (FDIC), National Credit Union Administration...more
As a part of Federal agencies’ issuance of their semi-annual Spring 2023 Regulatory Agenda, the CFPB has published its Spring 2023 Agency Rule List (“2023 List”). In that List, the CFPB has set forth the status of its...more
On June 1, 2023, the Consumer Financial Protection Bureau along with Federal Reserve, OCC, FDIC, NCUA and FHFA (collectively, the “Agencies”) issued a Notice of Proposed Rulemaking seeking comment on rules to implement...more
As witnessed by the rapid adoption of ChatGPT, which garnered 100 million users two months after its November 2022 release, use of generative artificial intelligence (AI) is growing. Similar to traditional AI, generative AI...more
In today’s data-driven decision-making environment, many businesses rely heavily on the accuracy, completeness and reliability of their data. Poor data quality can quickly undermine these efforts, leading to costly...more
In a past blog post, we predicted that data is arguably the products liability issue of the future. Dealing with data is already often a critical part of products liability lawsuits, but with the rise of artificial...more
Did you know… As a leader at an FDA-regulated company, you could be held criminally liable for misdemeanor FDA violations even if you did not know about the activities leading to the violation....more
Brands that sell goods on eCommerce websites such as Amazon, eBay, and Walmart, have undoubtedly been confronted with the issue of unauthorized resellers. Unauthorized resellers damage a Company’s brand, tarnish its company’s...more
Most people agree that product and service quality is key to client satisfaction, continued business, and referrals. To ensure ongoing success, organizations must maintain and improve quality efforts. A well-planned program...more
An ordinance (« arrêté ») was published in the French Official Gazette of 8 March 2022 that sets out a quality charter overseeing the professional practices of individuals responsible for the presentation of educational...more
The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed rule “Medical Devices: Quality System Regulation Amendments,” which will harmonize the current Quality System Regulation (QSR; 21 CFR Part 820)...more
In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be posting a series detailing the history...more
In the early stages of doing business, emerging businesses often use a distributor to introduce a product to the US market without a full sales force. This requires a solid distribution agreement. As your business expands,...more
Given the challenges of conducting clinical trials during the COVID-19 pandemic, many countries — including France — have allowed for some use of remote quality controls. In response to guidelines issued recently by European...more
On December 17, 2020, the Sacramento County Superior Court substantially limited the scope of waters to which the State Procedures for Discharges of Dredged and Fill Material (“Procedures”) apply through its decision in San...more