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
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more
On June 26, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance setting forth detailed requirements for the submission of Diversity Action Plans (DAPs) by sponsors of certain clinical studies involving...more
The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more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On May 2, 2023, the U.S. Food and Drug Administration (“FDA”) published draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” (the “Draft Guidance”). ...more
For those who will be regulated by USDA under the Animal Welfare Act for non-exempt facilities with birds not bred for use in research the time is ripe for you to submit comments to the proposed regulation published on Feb....more
Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more
In a notice published in the Federal Register (85 Fed. Reg. 58038) on September 17th, the U.S. Patent and Trademark Office announced that it was implementing a deferred-fee provisional patent application pilot program in...more
In this week’s episode, Ryan Severson discusses the Federal Health IT Strategic Plan, which was recently released by the Office of the National Coordinator for Health Information Technology (“ONC”). Mr. Severson discusses...more
The Department of Health and Human Services released its draft 2020-2025 Federal Health IT Strategic Plan for public comment. This article outlines the goals of the plan, as well as challenges in healthcare that ONC hopes the...more
The Department of Health and Human Services (HHS) and 16 other federal departments and agencies released a Notice of Proposed Rulemaking (NPRM) proposing to delay the compliance date for updates to the Common Rule for an...more
The Federal Policy for the Protection of Human Subjects, or the “Common Rule,” was originally published in 1991 and has been adopted and codified in separate regulations by HHS and 15 other federal departments and agencies. ...more
Those wishing to comment on revisions to the Federal Policy for Protection of Human Subjects (known as the “Common Rule”) could add a 30-day comment period extension to the things they were grateful for at this year’s...more
On September 2, 2015, HHS issued the long-awaited Notice of Proposed Rulemaking (NPRM) on revisions to the rules governing federally-funded research involving individuals, commonly referred to as the Common Rule (Subpart A of...more
In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more
The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common...more