In a remarkable federal human subject research policy development, it appears that the U.S. Department of Health and Human Services (HHS) Secretary's Advisory Committee on Human Research Protections (SACHRP) has been...more
Every week, the Array team reviews the latest news and analysis about the evolving field of eDiscovery to bring you the topics and trends you need to know. This week’s post covers the period of November 3-9. Here’s what’s...more
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more
In response to compliance officer personal liability concerns and increasing SEC regulations, Commissioner Peirce proposed the creation of a compliance advisory committee, which would bring together SEC regulators and...more
The U.S. Department of the Treasury and IRS on Sept. 17, 2024, issued Proposed Regulations on the Tribal General Welfare Exclusion Act of 2014 (the Act). The Proposed Regulations are an overdue win for Indian country,...more
The U.S. Food and Drug Administration (FDA or Agency) rejected the new drug application (NDA) for a drug marketing approval submitted by Lykos Therapeutics Inc. (Lykos) for its psychedelic MDMA drug on Aug. 9, 2024. Lykos...more
Director Review at the Patent Trial and Appeal Board (PTAB) remains a hot topic in patent law. The Director first established an interim process for Director Review in the wake of the Supreme Court’s 2021 decision in United...more
The California Division of Occupational Safety and Health (Cal/OSHA) will hold an advisory committee meeting on August 19, 2024, to solicit input on proposed regulations concerning enterprise-wide and egregious violations of...more
The Tax Court’s use of a functional analysis test to determine limited partner status in Soroban Capital Partners LP has had a ripple effect in the world of asset management. The decision’s impact will be felt in the tax and...more
In explaining the December 2023 amendments to Federal Rule of Evidence 702, the Advisory Committee called out several ways in which “many courts” had “incorrectly” applied Rule 702 and failed to adequately discharge their...more
Patent and Trademark Public Advisory Committees, 89 FR 44634 (May 21, 2024) (“seeking nominations for up to three members of its Patent Public Advisory Committee (PPAC) to advise the Director of the USPTO on patent policy,...more
One interesting aspect of the New York State Bar Association’s recent review of the ethical and legal issues raised by artificial intelligence in the practice of law was its suggestion that now might not be the best time to...more
The Securities and Exchange Commission announced an upcoming meeting of its Small Business Capital Formation Advisory Committee on May 6, 2024. The meeting will include a discussion of Regulation Crowdfunding (Reg CF) and...more
For a number of years, the Occupational Safety and Health Administration (OSHA) has promised a heat injury and illness prevention standard. To date, proposals related to heat injury and illness in outdoor settings have been...more
On July 24, 2023, the United States Patent and Trademark Office (USPTO or Office) promulgated a revised interim process for Director Review of Patent Trial and Appeal Board (PTAB or Board) decisions in proceedings under the...more
On January 10, the U.S. Securities and Exchange Commission (SEC) simultaneously approved eleven spot bitcoin Exchange Traded Funds (ETFs) on an accelerated basis based on its Order Granting Accelerated Approval of Proposed...more
On January 4, the USPTO announced the appointment of new leaders for the agency’s policy and communications teams. Sharon Israel will serve as the Chief Policy Officer and Director for International Affairs, and Jack...more
The FDA has announced the formation of the Digital Health Advisory Committee, a group dedicated to navigating the complexities of emerging DHTs like AI/ML, augmented reality and more. This development evidences the FDA’s...more
On October 5, the CFPB published the list of new members appointed to serve on the Consumer Advisory Board and each Council group....more
On October 5, the CFPB released new membership details for its advisory boards and councils, including the Consumer Advisory Board, Community Bank Advisory Council, Credit Union Advisory Council, and Academic Research...more
On July 24, 2023, the United States Patent and Trademark Office changed its procedures for the PTO Director’s review of certain decisions by the Patent Trial and Appeal Board. The decisions in question are those decisions of...more
There is big news in the world of multidistrict litigation: On August 15, 2023, the public comment period opened on a new proposed amendment to the Federal Rules of Civil Procedure specifically addressing case management in...more
While the European Union sprints ahead with draft legislation to closely regulate artificial intelligence (AI), the United States (U.S.) lags behind its western counterpart, leaving little regulatory guidance for U.S. AI...more
The UK standards will aim to increase the comparability and value of reported information for investors. The UK government announced on 2 August 2023 that it will develop standards for company sustainability disclosures...more
On July 24, 2023, the US Patent & Trademark Office (PTO) announced that a revised interim Director Review (DR) process and Appeals Review Panel (ARP) process will replace the Precedential Opinion Panel Process. Updates to the...more