DE Under 3: OFCCP Resurrects Proposal for Monthly CC-257 Employment Utilization Reports for Construction Contractors
The NYDFS Updates Its Stringent Cybersecurity Regulations. Is This a Bellwether of Coming Industry Change? - The Consumer Finance Podcast
Non-Compete Agreements: An Endangered Species?
DE Under 3: Behind the Scenes of EEOC’s Full Commission Hearing
DE Under 3: Data Gathering & Data Delivery
Kilptrick Townsend Digital Assets Minute | U.S. Treasury—Comments on Digital Assets Development Due August 8th
DE Under 3: Updated EEOC COVID-19 Technical Assistance Guidance, Case Decision & Wage & Hour Division Proposed Rule
CA DFPI Request for Comment on Cryptocurrency-Related Financial Products and Services - The Consumer Finance Podcast
DE Under 3: New Data Collection Burdens, NLRB’s Ruling Regarding Union Election Dismissals, and OMB’s Tech Modernization Fund
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
DE Under 3: OFCCP Contractor Portal & Request for Comments for Functional Affirmative Action Programs (FAAPs)
2BInformed: The Future of Fluoride in Drinking Water, the New TSCA Fees Rule, and the Drinking Water Contaminant Candidate List 5
Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act
Recent Actions on Ag Biotech by EPA’s Emerging Technologies Branch
Podcast: Private Fund Regulatory Update: Post-U.S. Government Shutdown
III-42-The New Overtime Rule and Antitrust Issues With Your Non-Competes
[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?
The Centers for Medicare & Medicaid Services (CMS) issued the final procedural notice on Transitional Coverage for Emerging Technologies (TCET), effective as of August 12, 2024. TCET is a new pathway that uses existing...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 United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is...more
The United States Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking to reschedule marijuana from schedule I of the Federal Controlled Substance Act (“CSA”) to schedule III. As a reminder,...more
On May 21, 2024, the DEA finally published its proposed rule related to rescheduling marijuana and commenced a 60-day period where the public can submit comments regarding DEA's proposed move to reschedule marijuana (the...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
As we previously reported, the Treasury Department released a 2022 report on Competition in the Markets for Beer, Wine, and Spirits (the Competition Report) recommending, in part, that the Alcohol and Tobacco Tax and Trade...more
The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information regarding revised FDA labeling guidance for...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
On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...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
On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing complexity of rapidly evolving...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 March 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (“Draft...more
On January 4, 2023, the Biden Administration belatedly released the Fall 2022 Unified Agenda of Regulatory and Deregulatory Actions (the Unified Agenda). Typically published twice a year in the spring and the fall by the...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
On November 29, the U.S. Food and Drug Administration (FDA) issued two guidance documents about food allergen labeling requirements. First, FDA issued a draft guidance titled Questions and Answers Regarding Food Allergens,...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
On November 7, the U.S. Patent and Trademark Office (USPTO) published a request for comments on areas for USPTO-FDA collaboration and engagement. The USPTO also announced a related public listening session to be held...more