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  • Article

    AI Legal & Regulatory News—Week Of 2/12/24

    Below is this week's tracker of the latest legal and regulatory developments in the United States and in the EU. Sign up here to ensure you do not miss an update.
    GlobalTechnology
    Steptoe LLP
    Steptoe LLP
  • Article

    Encryption - Recent Developments In Japan

    United StatesCorporate/Commercial Law
    Steptoe LLP
    Steptoe LLP
  • Article

    Summary Of Administration's Proposed Encryption Legislation

United StatesEnvironment
Steptoe LLP
Steptoe LLP
  • Article

    Clarity Delayed: Legislative Delays Threaten Crypto Market Structure Framework

    The Digital Asset Market Clarity Act promised to bring regulatory stability to the cryptocurrency industry, but faces mounting obstacles to congressional approval. With traditional banks opposing activity-based rewards provisions and law enforcement groups challenging anti-money laundering carve-outs, the bill's path forward has narrowed considerably.
    United StatesFinance and Banking
    Steptoe LLP
    Steptoe LLP
  • Article

    FDA Issues Draft Guidance On Container Closure Systems For Human Drugs And Biological Products

    The FDA has released new draft guidance establishing a comprehensive risk-based framework for evaluating container closure systems used in pharmaceutical packaging, marking a significant update from its 1999 guidance. This framework addresses five critical factors including material safety, environmental protection, performance standards, manufacturing impacts, and storage considerations, with particular emphasis on leachables assessment and quality control programs across different drug delivery routes.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Steptoe LLP
    Steptoe LLP
  • Article

    FDA Publishes Final Rule Revising Bases And Procedures For Revoking FCN Authorizations

    The US Food and Drug Administration (FDA) published a Final Rule on March 22, 2024, amending its regulation at 21 C.F.R. § 170.105 to provide additional bases upon which the agency may determine that a Food Contact Notification (FCN) is no longer effective.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Steptoe LLP
    Steptoe LLP
  • Article

    Department Of War Pauses CMMC Phase II Implementation & Launches 60-Day Program Review

    The Department of War has suspended Phase II requirements of the Cybersecurity Maturity Model Certification program, halting the planned November 2026 rollout that would have required third-party assessments for defense contractors. While the suspension provides relief from certification deadlines, contractors must continue meeting existing cybersecurity obligations under DFARS and NIST SP 800-171 as the DoW conducts a 60-day program review.
    United StatesGovernment, Public Sector
    Steptoe LLP
    Steptoe LLP
  • Article

    Gold Eagle AI-Powered Vulnerability Coordination and Remediation Platform Takes Flight

    The White House has launched Gold Eagle, a new AI-powered cybersecurity clearinghouse that coordinates vulnerability identification and patching across federal agencies and private industry. This initiative, stemming from Executive Order 14409, leverages frontier artificial intelligence to intake, prioritize, and verify software vulnerabilities with the goal of accelerating remediation across critical infrastructure. Companies operating in affected sectors must now navigate how this government-industry part
    United StatesGovernment, Public Sector
    Steptoe LLP
    Steptoe LLP
  • Article

    New U.S. Sanctions On The Government Of Iran And Iranian Financial Institutions

    Effective February 6, 2012, President Obama issued an Executive Order (EO) expanding sanctions against the Government of Iran and Iranian financial institutions.
    United StatesInternational Law
    Steptoe LLP
    Steptoe LLP
  • Article

    OFAC Issues General License For Earthquake Relief In Syria

    Recognizing the importance of humanitarian aid to support rescue and recovery efforts in Syria, the US Department of the Treasury...
    United StatesInternational Law
    Steptoe LLP
    Steptoe LLP
  • Article

    OFAC Issues Guidance On Exports Of Personal Communications Services And Software To Iran

    On March 20, 2012, the Treasury Department’s Office of Foreign Assets Control (OFAC) issued interpretive guidance and a new licensing policy regarding its rule authorizing the export to Iran of certain services and software incident to the exchange of personal communications over the Internet.
    United StatesInternational Law
    Steptoe LLP
    Steptoe LLP
  • Article

    Unveiling The Landmark IPEF Supply Chain Agreement

    The members of the Indo-Pacific Economic Framework (IPEF) reached a significant milestone at the IPEF Ministerial Meeting in Detroit, Michigan with the substantial conclusion of negotiations on a landmark...
    United StatesInternational Law
    Steptoe LLP
    Steptoe LLP
  • Article

    ECJ Prolongs Market Access For "Free Riders"

    On 22 May 2008, the European Court of Justice ("ECJ") delivered its judgment in case C-361/06, Feinchemie Schwebda and Bayer CropScience v College voor detoelating van bestrijdingsmiddelen.
    European UnionEnergy and Natural Resources
    Steptoe LLP
    Steptoe LLP
  • Article

    REACH: Only Representative Rules Change Again

    Pre-registration of substances under REACH started on 1 June 2008 and ends on 1 December 2008. Substances on their own, in preparations or in articles which are not pre-registered during that period cannot be manufactured in the EU.
    European UnionEnergy and Natural Resources
    Steptoe LLP
    Steptoe LLP
  • Article

    Regulatory Pulse Pharma And Medical Devices Newsletter: Issue #3

    The European Health Data Space Regulation (EHDS Regulation) entered into force on March 26, 2025. The purpose of the Regulation is to establish a common framework for the use and exchange...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Steptoe LLP
    Steptoe LLP
  • Article

    EU Enhances Economic Sanctions on Luxury and Dual Use Goods against Syria

    On 15 June 2012, the Council of the European Union (Council) approved Council Regulation (EU) No 11222/12, enhancing EU sanctions on luxury and dual use goods exported to Syria.
    European UnionInternational Law
    Steptoe LLP
    Steptoe LLP
  • Article

    GDPR: Designation And Position Of Data Protection Officer (DPO) Under European Regulators' Scrutiny

    On March 15, 2023, the European Data Protection Board (EDPB) announced the launch of a coordinated enforcement action regarding the designation and position...
    European UnionPrivacy
    Steptoe LLP
    Steptoe LLP
  • Article

    Israel And Egypt Advance A $35 Billion Gas Deal, But Political Obstacles Remain

    In December, Israel and Egypt formally announced a long-awaited $35 billion natural gas deal that will see Jerusalem export over 130 billion cubic meters (bcm) of natural gas from its Leviathan field to Cairo via pipeline until 2040.
    GlobalEnergy and Natural Resources
    Steptoe LLP
    Steptoe LLP
  • Article

    Regional Spillover In The Middle East Risks Supply Chain Disruptions And Violence Escalation

    As the US-Israel-Iran conflict in the Middle East enters its third week, further regional spillover and escalation appear more likely than a decisive conclusion in the near term.
    GlobalEnergy and Natural Resources
    Steptoe LLP
    Steptoe LLP
  • Article

    Stepwise Risk Outlook Deep Dive: Hurricanes, Typhoons Leading To Escalating Supply Chain Risks

    Over the last month, both the Atlantic and the Pacific have seen historic storms that have taken hundreds of lives and dealt billions in infrastructure damage and property loss.
    GlobalEnvironment
    Steptoe LLP
    Steptoe LLP
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