Consumer Finance Monitor Podcast Episode: Regulators Escalate Focus on the Risks of Bank Relationships with Fintechs and Other Third Parties
DE Under 3: OFCCP Resurrects Proposal for Monthly CC-257 Employment Utilization Reports for Construction Contractors
DE Under 3: Updated EEOC COVID-19 Technical Assistance Guidance, Case Decision & Wage & Hour Division Proposed Rule
Digital Assets Regulation Framework: Commerce Solicits Public Comment
DE Under 3: EEOC & DOJ Technical Guidance for Employer’s AI Use; Upcoming EEOC Hearing; Event for Mental Health in the Workplace
Comment Deadline Approaching: Proposed Amendments Restricting Use of Prop 65 Short-Form Warnings
2BInformed: The Future of Fluoride in Drinking Water, the New TSCA Fees Rule, and the Drinking Water Contaminant Candidate List 5
Recent Actions on Ag Biotech by EPA’s Emerging Technologies Branch
III-44- A Little Help From The DOL
[WEBINAR] Laying the Foundation for Maximizing Benefits Around Emerging Technologies
[WEBINAR] Fairly (or Unfairly?) Traceable: Are Discharges Through Groundwater Subject to the Clean Water Act?
Episode 014: Business Divorce Stories: Business Appraiser Tony Cotrupe and Attorney Jeff Eilender
On July 23, the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) announced a coordinated initiative to address health risks associated with so-called “ultra-processed foods.”...more
On July 25, the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA), unveiled the highly anticipated joint request...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On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance.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
FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more
On May 13, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced a public Request for Information to “identify and eliminate outdated or unnecessary...more
In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more
On January 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would set a maximum nicotine level in combusted cigarettes and certain other combusted tobacco products....more
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
The U.S. Food and Drug Administration (FDA) recently published revisions to its multichapter draft guidance for industry on Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food (the Draft Guidance). 89...more
Report on Research Compliance 20, no. 12 (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more
On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more
FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more
After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more
The U.S. Food and Drug Administration (FDA) issued draft guidance on August 7, 2023, clarifying new requirements for cosmetic facility registrations and product listings under the Modernization of Cosmetics Regulation Act of...more
On July 27, 2023, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), along with Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bernie...more
Last month, the FDA’s Office of Cosmetics and Colors issued a Draft Guidance encouraging tattoo ink manufacturers and distributors to recognize situations in which these products may become contaminated with microorganisms,...more
In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more
DA recently released Draft Guidance on the Agency’s expanded use of remote regulatory assessments (RRAs) to review regulated establishments and / or their records. FDA outlines how it intends this tool to be incorporated...more
On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more
In the medical device industry, there exists a longstanding divide between device manufacturers (i.e., those who design, manufacture, fabricate, or process a finished device) and the third-party entities that service the...more
The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations issued by HHS or its constituent...more
This week, FDA published a proposed rule that would amend its medical product "intended use" regulations, 21 CFR §§ 201.128 and 801.4 and replace the 2017 Final Rule about the same issue that never became effective....more
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
The past year has seen a veritable tidal wave of consumer product marketing claiming that cannabidiol (CBD) infused or derived products cure or treat cancer, epilepsy, anxiety, inflammation, diabetes, Alzheimer’s disease,...more