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On March 12, the US Securities and Exchange Commission (SEC), via a No Action Letter, issued interpretive guidance clarifying what constitutes “reasonable steps” issuers can take to verify purchasers’ accredited investor status, as required under Rule 506(c) of Regulation D under the Securities Act of 1933, as amended (Securities Act) (Rule 506(c)).
On March 10, the US Department of Health and Human Services (HHS) announced that newly confirmed HHS Secretary Robert F. Kennedy Jr. has directed acting US Food and Drug Administration (FDA) Commissioner Dr. Sara Brenner to “take steps to explore potential rulemaking to revise its Substances Generally Recognized as Safe [GRAS] Final Rule and related guidance to eliminate the self-affirmed GRAS pathway.”
President Trump’s first months in office have been busy, but, in the export control world, we have been grateful for a brief respite from the mind-bending, hundreds-of-pages-long, industry-changing rules that the US Department of Commerce’s Bureau of Industry and Security (BIS) issued during the last stretch of President Biden’s term — sometimes more than one per day!
On Thursday, September 12, 2024, the US Commerce Department’s Bureau of Industry and Security (BIS) issued a final rule updating the agency’s policies on voluntary self-disclosures and the Guidance on Charging and Penalty Determinations in Settlement of Administrative Enforcement Cases (BIS Penalty Guidelines).
On the litigation front, a federal judge denied an attempt by the Cookware Sustainability Alliance (CSA) to halt Minnesota’s current ban on intentionally added per- and polyfluoroalkyl substances (PFAS) in cookware. However, the industry group continues to advocate for cookware exemptions with a track record of success across the nation.
On October 23, 2024, the US Department of Commerce’s Bureau of Industry and Security (BIS) and the US State Department’s Directorate of Defense Trade Controls (DDTC) issued a tranche of new rules to overhaul and modernize US export controls on space-related items.
On September 6, 2024, the US Department of Commerce’s Bureau of Industry and Security (BIS) introduced an interim final rule that imposed worldwide export controls on slew of advanced technologies to align with the Implemented Export Controls (IEC) of international partners.
Join AFS Life Sciences Partner Stephanie Trunk and Darshan Kulkarni, Life Sciences regulatory and compliance attorney, as they explore the major shifts occurring in the pharmaceutical industry under the Trump Administration.
The full scope of the Trump Administration’s deregulatory efforts in the environmental space was recently made clear with a series of announcements from US Environmental Protection Agency (EPA) Administrator Lee Zeldin.
This January 16 interim final rule by the US Department of Commerce’s Bureau of Industry and Security (BIS) imposes a broader license requirement on two types of parties: “front-end fabricators” and Outsourced Semiconductor Assembly and Test (OSAT) companies.
On December 5, 2024, the US Department of Commerce’s Bureau of Industry and Security (BIS) promulgated an interim final rule (the December IFR) expanding its authority to restrict the dissemination of advanced chip technology and semiconductor manufacturing equipment (SME) through controls on new items including high bandwidth memory (HBM) commodities, two new foreign direct product rules (FDPRs), expanded end-use and US person restrictions, and clarifying the export control status of software keys.
Final order requires company to pay over $630,000 in fines and change its business practices.
ArentFox Schiff attorneys William Ziegelmueller and Kaitlin Klamann attended the American Bar Association’s (ABA) 40th White Collar Crime Institute (WCCI) March 5-7, 2025, in Miami, Florida.
Headlines that Matter for Companies and Executives in Regulated Industries
The first weeks of the Trump Administration have been defined by executive orders and new policies that were immediately challenged on constitutional or statutory grounds.
On February 14, the new general counsel of the National Labor Relations Board (NLRB), William Cowen, rescinded more than 25 previously issued policy memoranda.
Across all industries, family offices and their owners and management teams face rapidly evolving challenges, opportunities, and risks in the dynamic environment that is 2025. Here are six issues that family offices should consider and be mindful of this year.
In the fast-paced and competitive world of furniture and design, where partnerships and innovations flourish, but consumers’ attention is increasingly divided, legal disputes are increasingly common.
Welcome to the March 2025 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.
Jessica J. Birnbaum of ArentFox Schiff will speak at the annual Women’s History Month Summit hosted by the Chicago Bar Association (CBA).
In a precedential opinion issued on March 6, the Federal Circuit affirmed the US District Court for the Eastern District of Virginia that the claims in ImmunoGen’s US patent application 14/509,809 (“the ’809 application,” published on May 14, 2015, as US 2015/0132323) were obvious.
In Kroy IP Holdings, LLC v. Groupon, Inc., 127 F.4th 1376 (Fed. Cir. 2025), the Federal Circuit held that patentees in district court are not collaterally estopped from asserting claims that were not immaterially different from other claims of the same patent that the US Patent Trial and Appeal Board (PTAB) already held to be unpatentable.
On March 5, the US Court of Appeals for the Federal Circuit issued a decision in Lashify, Inc. v. International Trade Commission, No. 23-1245, vacating in part the International Trade Commission’s (ITC) determination that Lashify failed to satisfy the economic prong of the Section 337 domestic industry requirement and affirming in part the finding that Lashify failed to satisfy the technical prong of the domestic industry requirement.
On March 3, the US Securities and Exchange Commission’s (SEC) Division of Corporation Finance announced that it is expanding the accommodations available to issuers submitting nonpublic draft registration statements for staff review.
On January 20, the US Department of Homeland Security (DHS) rescinded 2021 guidelines that previously designated hospitals, clinics, and other health care facilities as “protected areas” and limited immigration enforcement actions in or near such locations.