Top challenges with Compliance Management
Solicitors General Insights: The Tale of Two Washingtons — Regulatory Oversight Podcast
The Capital Ratio Podcast | Entering the US Banking Market
Compliance Tip of the Day: COSO Objective 3 – Control Activities
Solicitors General Insights: The Legal Frontlines in Iowa and Indiana — Regulatory Oversight Podcast
Cannabis Law Now Podcast - Cannabis in the Show Me State: An Interview with BeLeaf Medical's Mitch Meyers
2 Gurus Talk Compliance – Episode 54 – The FCPA is Back On Edition
Compliance Tip of the Day: Board Oversight on Internal Controls
Healthcare Enterprise Risk Management
Understanding MALPB Charters: A Collaborative Approach to Banking Innovation — Payments Pros – The Payments Law Podcast
State AGs Unite: New Privacy Task Force Signals Shift in Regulatory Power Dynamics — Regulatory Oversight Podcast
The fatal flaws in the 2023 CRA rule
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
State AGs Unite: New Privacy Task Force Signals Shift in Regulatory Power Dynamics — The Consumer Finance Podcast
From Cell Phones to Tractors: The Right to Repair Movement Drives On — Regulatory Oversight Podcast
AI Legislation: The Statewide Spotlight - Regulatory Oversight Podcast
AI Legislation: The Statewide Spotlight — The Consumer Finance Podcast
Solicitors General Insights: A Deep Dive With Mississippi and Tennessee Solicitors General — Regulatory Oversight Podcast
Leadership and Innovation at the Illinois AG's Office — Regulatory Oversight Podcast
Navigating the Future of Payment Stablecoins: Legislative Updates and Market Implications — Payments Pros – The Payments Law Podcast
California’s Department of Toxic Substances Control (DTSC) proposed adding microplastics as a Candidate Chemical to be regulated under the Safer Consumer Products (SCP) program on June 20, 2025. This action and its subsequent...more
In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA. Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more
In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more
On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more
On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more
On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more
On May 27, the Texas Legislature sent Senate Bill 3 (SB3) to Gov. Greg Abbott for signature, marking a potentially seismic shift in the legal landscape for hemp-derived cannabinoid products in the state. If signed into law –...more
On June 4, 2025, the U.S. Food and Drug Administration issued a public advisory urging consumers not to inhale nitrous oxide (N2O) from commercial dispensers, including canisters, tanks and portable chargers. The advisory...more
On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more
Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more
The Food and Drug Administration (FDA) recently issued General Correspondence Letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories “after discovering data that was falsified or otherwise...more
Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more
As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early...more
Consumer product companies are facing unprecedented scrutiny as the Consumer Product Safety Commission (CPSC) intensifies its regulatory oversight. With heightened civil penalties, increased monitoring of e-commerce...more
On June 19 to June 20, 2025, the European Union (EU) Horizon Europe projects ACCORDs, iCare, MACRAMÉ, and nanoPASS are hosting a joint summit to address the needs of industry and regulators in assessing the safety and...more
In this episode of Regulatory Oversight, Stephen Piepgrass is joined by colleagues Brad Weber and Christy Matelis from the firm's Antitrust Practice Group to explore the evolving landscape of right-to-repair laws across the...more
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. This announcement applies to facilities that produce...more
The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more
The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more
Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements governing distribution chain compliance. Given the evolving and expanding requirements for device...more
The Trump administration may eliminate the Consumer Product Safety Commission (CPSC), according to a recently leaked draft fiscal year 2026 budget for the Department of Health and Human Services (HHS). This “pre-decisional”...more
In recent years, the drone (or remotely piloted aircraft system (RPAS)) industry has experienced rapid growth, particularly in commercial applications. As drones become integral to business operations, regulations must keep...more
In recent years, the safety of baby food has become a top priority for state attorneys general (AG) and federal agencies. In April 2021, the U.S. Food and Drug Administration (FDA) announced its “Closer to Zero” plan to...more
The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products and courts, which has already been the subject of numerous decisions. Recently,...more
Reckitt Benckiser Tastes Sweet Success as Mucinex Honey False Ad Dismissed - Plaintiffs alleging that Reckitt Benckiser falsely advertised certain Mucinex products as containing honey failed to sufficiently allege that the...more