Episodes

  • Who Bears the Risk? EU Court of Justice Clarifies the Boundaries of Distributor and Manufacturer Obligations Under the EU Medical Devices Regulation
    Oct 30 2026

    This episode explores a pivotal EU court ruling on distributor obligations under the Medical Devices Regulation, clarifying due care requirements and reinforcing manufacturers’ primary responsibility for product classification in the medical device supply chain.

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    3 mins
  • FDA Launches Pursuit of Fit-For-Purpose Regulatory Framework to Advance Rare Disease Drug Development
    Oct 27 2026

    This episode breaks down the FDA’s new Rare Disease Framework Initiative—launched in October 2026—which aims to consistently apply regulatory flexibility for rare disease therapies by establishing a centralized innovation hub, engaging outside experts, and implementing risk-based approaches to evidence and manufacturing standards.


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    5 mins
  • Manhattan District Attorney Launches New Corporate Crime and Antitrust Task Force
    Oct 19 2026

    This episode discusses the Manhattan District Attorney’s new Corporate Crime and Antitrust Task Force, highlighting expanded state-level enforcement risks—including AI-facilitated offenses—for organizations and their leaders, with a focus on "systemic accountability" and heightened scrutiny of key sectors and counterparties.

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    4 mins
  • SEC Proposes Comprehensive Overhaul of Rule 17a-7
    Oct 19 2026

    This episode provides a concise overview of the SEC’s October 9, 2026 proposed Rule 17A-7 under the 1940 Act, highlighting expanded eligibility for cross-trades, updated pricing methods, new compliance and oversight responsibilities, and the operational and reporting impacts for fund advisors and compliance officers.

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    4 mins
  • SEC Staff Greenlights Directed Voting Programs for Funds
    Sep 30 2026

    This episode covers the SEC’s September 2026 no-action letter to the Mutual Fund Directors Forum, explaining the approval of a “Directed Voting Program” for mutual funds, how it incorporates retail voting frameworks and governance safeguards under the 1940 Act, and what it means for fund shareholders amid rising proxy campaign costs.

    To read the alert that this AI-generated podcast is based on, please visit: https://www.ropesgray.com/en/insights/alerts/2026/09/sec-staff-greenlights-directed-voting-programs-for-funds

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    5 mins
  • Ninth Circuit Rules Generative AI Outputs Are Not "Stripped Copies" Under the DMCA
    Sep 23 2026

    This episode breaks down the Ninth Circuit’s September 2026 decision in Dovi v. GitHub, Inc., exploring how the DMCA applies to generative AI coding tools and what the ruling means for developers, enterprises, and investors.

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    5 mins
  • DOJ's New National Fraud Enforcement Division Signals Where It Will Focus in Inaugural Memorandum
    Aug 17 2026

    This episode explores the Department of Justice's new National Fraud Enforcement Division, highlighting its data-driven approach to targeting fraud against taxpayer dollars and advising companies in high-risk industries to proactively strengthen compliance and data analytics.

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    4 mins
  • Delaware and New York State Courts Reject Unusual Theory Under the Securities Act
    Aug 14 2026

    This episode examines recent Delaware and New York court decisions dismissing Securities Act claims against mutual funds, clarifying that industry-standard, GAAP-compliant accounting practices do not constitute material misstatements or omissions under federal securities law.

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    3 mins