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
The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more
Since the publication of our article on what to expect for stem cell regulation under the new administration, we’ve been closely monitoring the administration’s enhanced focus on the same....more
The U.S. Food and Drug Administration (FDA) is overhauling its approach to post-market oversight of food chemicals, marked by the proposed rollout of a new Post-Market Assessment Prioritization Tool. The FDA first announced...more
On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national...more
The U.S. Food and Drug Administration (FDA) announced Tuesday a “Commissioner’s National Priority Voucher” (CNPV) program, which will provide a “limited number” of vouchers to sponsors of drug products that are “aligned with...more
On June 17, 2025, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency is creating a new pilot program called the Commissioner’s National Priority Voucher (CNPV). The program is intended...more
On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more
The US Food and Drug Administration recently announced a major initiative to strengthen oversight of food additives and other food-related chemicals. The agency described this as a “stronger, more systematic review process”...more
The U.S. Food and Drug Administration (FDA) has announced a new initiative to systematically review the safety of chemicals already in the nation's food supply....more
The U.S. Food and Drug Administration (FDA) recently announced plans to update its post-market food chemical review program. In its announcement, FDA explained that its forthcoming plans will take a proactive approach to...more
Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant changes that have occurred at the Food and Drug Administration (FDA or Agency) during...more
The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) on April 22, 2025, announced their intent to phase out the use of certain food additives, including petrochemical-based dyes,...more
On April 21, 2025, it was reported that the U.S. Department of Health and Human Services (HHS) has released a media advisory describing the Food and Drug Administration’s (FDA) intention to remove petroleum-based synthetic...more
As spring arrived in the mid-Atlantic region, the Department of Health and Human Services (HHS) under Robert F. Kennedy, Jr. followed through with a previously announced Reduction in Force (RIF) that reduced the department’s...more
The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more
On March 10, 2025, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced in a press release that he has directed the Food and Drug Administration (FDA) to explore rulemaking to implement a...more
Throughout 2024, the U.S. Food and Drug Administration (FDA) endeavored to curb sales of unauthorized electronic nicotine delivery systems (ENDS) in the U.S. In light of persistent demand for flavored ENDS — nearly all of...more
Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more
It has been widely reported and confirmed publicly that, on August 29, the U.S. Department of Health and Human Services (HHS) sent a letter to the Drug Enforcement Administration (DEA) recommending that cannabis be moved from...more
A proposed U.S. Food and Drug Administration (FDA) restructuring plan seeks to move cosmetics regulation and color certification out of the Center for Food Safety and Applied Nutrition and into the Office of Chief Scientist...more
U.S. Food and Drug Administration (FDA) Commissioner Robert M. Califf announced in a Jan. 31 statement that the agency intends to reorganize its Human Foods Program and Office of Regulatory Affairs (ORA) after receiving the...more
Introduction - Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA...more
In a year-end $1.7 trillion spending package in late December, Congress voted to increase FDA's oversight of cosmetics and their ingredients. A portion of the bill titled the Modernization of Cosmetics Regulation Act requires...more
LEGISLATION, REGULATIONS & STANDARDS - Omnibus Spending Bill Includes Congressional Notes to FDA - President Biden has signed a spending bill that includes additional funding for the U.S. Food and Drug Administration (FDA)...more
The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more