The BIS Committee on Payments and Market Infrastructures (CPMI) and the International Organization of Securities Commissions (IOSCO) have published two reports addressing financial market infrastructures' (FMIs) management of...more
On October 29, 2025, the FDA released a new draft guidance “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies”...more
The European Banking Authority (EBA) has launched a consultation on its revised guidelines for the supervisory review and evaluation process (SREP) and supervisory stress testing, mandated under the Capital Requirements...more
The Single Resolution Board (SRB) has launched a consultation on new operational guidance for banks' communication in resolution scenarios, along with a communication testing supplement to its existing operational guidance on...more
On September 23, 2025, the FDA published three new draft guidances that give insight into a regulatory framework for cell and gene therapies (CGTs) that is now coming into focus. By releasing these guidances together, FDA is...more
The European Banking Authority (EBA) launched a consultation on proposed revisions to its guidelines on internal governance under the Capital Requirements Directive (CRD). The revisions form part of the EBA's broader roadmap...more
Bullying, harassment and violence set to be conduct issues under new FCA Rule - The Financial Conduct Authority (the “FCA”) recently published its Policy Statement and Consultation on non‑financial misconduct (“CP25/18”). ...more
In a previous alert, “FCA D&I Standards for Large Firms Abandoned (for now), Non-financial Misconduct Rules Delayed (but Still Important),” we discussed the proposals put forward by the UK Financial Conduct Authority (FCA)...more
On October 10, 2024, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced its agenda of proposed guidance documents to be published or developed in the 2025 fiscal year (FY)....more
California courts are readying new standards for court interpreters with most changes focused on ethical behavior during remote and hybrid court proceedings. The proposed revisions to the Professional Standards and Ethics for...more
Good amicus briefs contribute to the development of the law and the administration of justice. They can benefit courts, parties, and, of course, the amici themselves. Courts benefit from having a more robust exposition of the...more
Over one year ago, on October 3, 2023, the Federal Deposit Insurance Corporation (FDIC) proposed supervisory guidelines that would establish standards for corporate governance and risk management for all state non-member...more
Recently, the United States Patent and Trademark Office (USPTO) released proposed guidelines addressing the complex issue of AI inventorship. The PTO is not the only agency attempting to tackle this issue; jurisdictions...more
California currently deploys almost 35 GW of renewable energy but expects another 148 GW of renewables will be needed to meet the state’s overarching 2045 clean energy goals. To fill this gap, California expects offshore wind...more
A group of federal agencies have finalized reconsideration of value (ROV) guidance for residential real estate valuations. The agencies are the Comptroller of the Currency (OCC), Consumer Financial Protection Bureau (CFPB),...more
The U.S. Department of the Treasury and IRS recently issued guidance aimed at curtailing purportedly abusive basis-shifting transactions utilized by businesses taxed as partnerships. This guidance represents additional...more
On April 12, 2024, the Treasury Department and Internal Revenue Service (IRS) issued proposed Treasury Regulations (REG-115710-22) providing comprehensive guidance for applying the one-percent excise tax owed on corporate...more
The Department of Treasury, the Internal Revenue Service, and the Department of Energy finalized guidance on the requirements for new and used clean vehicles to be eligible for federal tax credits....more
Marking the first effort to establish an artificial intelligence (“AI”) governance structure for the federal government, the AI Memorandum contains requirements and recommendations for federal agencies’ AI use that...more
Almost seven months after seeking public comment on an initial proposed version, and more than seven years after first attempting to update its guidance on the issue, the Equal Employment Opportunity Commission issued on...more
The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions....more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
ACI’s 8th Annual Legal, Regulatory, and Compliance Forum on Fintech & Emerging Payment Systems will provide in-depth guidance on the latest regulatory developments at the Federal and State Level that you need to be aware of....more
On January 17, 2024, the New York State Department of Financial Services (NYDFS) issued a proposed Circular Letter that provides guidance for authorized insurers using external consumer data and information sources (ECDIS)...more
2023 was a busy year at the Patent Trial and Appeal Board, as post-grant practice continued to evolve at a rapid pace. At the United States Patent and Trademark Office, there were big developments in Director Review and...more