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K2 Integrity

SEC’s New Cyber Disclosure Rule: Challenges, Consequences, And Compliance

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The U.S. Securities and Exchange Commission’s (SEC) impending cyber disclosure rule, slated to commence on 15 December 2023, underscores an imperative shift towards a more transparent and accountable cybersecurity posture for...more

Ankura

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

Ankura on

On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

MoFo Life Sciences

FDA’S Loud And Clear Message: Engage With FDA Early And Formally

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On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab application based on the ORIENT-11 trial conducted exclusively in...more

Carlton Fields

On Cybersecurity, Grab the Low-Hanging Fruit

Carlton Fields on

SEC Tells Firms to Stop Missing the Basics on Cybersecurity - The SEC’s Office of Compliance Inspections and Examinations (OCIE) reported in a recent Risk Alert that many investment advisers and broker-dealers are failing to...more

Kramer Levin Naftalis & Frankel LLP

Artificial Intelligence in Financial Services: Tips for Risk Management

Technology is rapidly changing the way investment advisers deliver services to their clients. Funds are now using a range of technology solutions, from advanced trading algorithms to artificial intelligence and machine...more

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