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 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
The U.S. Food and Drug Administration (FDA) announced on July 14, 2025, that it is extending the public comment period on its proposed method for ranking chemicals in the food supply by 30 days, to August 18, 2025. As...more
The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) issued a Request for Information (RFI) on May 13, 2025, titled "Ensuring Lawful Regulation and Unleashing Innovation to...more
Employer-sponsored health plans would be required to cover over-the-counter contraception, including condoms and emergency contraception, without a prescription and without cost sharing under newly proposed Affordable Care...more
On September 13, 2024, the U.S. Environmental Protection Agency (EPA) began a public comment period on a proposed update to its Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing...more
The US Food and Drug Administration (FDA) issued final guidance titled Foods Derived from Plants Produced Using Genome Editing (Genome-Edited Plants Guidance), describing the agency’s approach for evaluating the safety of...more
The Texas Health and Human Services Commission, on behalf of the Texas Department of State Health Services, recently announced that it was accepting public comments to the current rules governing consumer hemp products in the...more
On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: Questions and Answers,”...more
Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...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) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from...more
On May 31, the FDA issued a proposed rule to amend prescription drug labeling regulations to require a new type of Medication Guide, specifically a Patient Medication Information guide, for essentially all FDA-approved...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
The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more
The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more
On February 23, 2023, the Food and Drug Administration (FDA) announced the issuance of a draft guidance document entitled “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements: Guidance for Industry.”...more
On September 28, 2022, the U.S. Food and Drug Administration issued a Proposed Rule to revise the criteria for when foods can be labeled with the nutrient content claim “healthy.” Since 1994, FDA has recognized that when a...more
Here is what you need to know about the FDA's recent proposed rule on "healthy" labeling. - On September 29, 2022, FDA proposed an amendment to the existing regulation (21 CFR § 101.65) on when “healthy” or similar terms...more
USPTO News - ..On October 19, 2022 the USPTO issued a report titled “Where are U.S. women patentees? Assessing three decades of growth” examining trends in women’s patenting in the U.S. from 1990-2019. ..Director...more
Last week the U.S. Food and Drug Administration (FDA) issued a long-awaited draft guidance, Human Gene Therapy Products Incorporating Human Genome Editing, that addresses key considerations for the development of gene therapy...more
On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more
Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,” regarding formal meetings between FDA and meeting...more
During the COVID-19 public health emergency, the United States Food and Drug Administration (FDA) has issued hundreds of Emergency Use Authorizations (EUAs) and numerous enforcement policies to facilitate the availability of...more
During the COVID-19 pandemic, decentralized clinical trials and remote patient monitoring and data acquisition became a necessity, accelerating the use of digital health technologies in clinical trials. Acknowledging that...more
Last week the FDA issued another draft guidance in its series of recent guidance documents setting forth the agency’s views regarding the generation and use of Real-World Data (RWD) and Real-World Evidence (RWE) for...more