Last month we provided an update on the UK Government’s draft post-market surveillance statutory instrument (“PMS SI”) and the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) intention to run a further public consultation on proposed changes to pre-market medical device regulation under an upcoming statutory instrument (“Pre-Market SI”).
On 14 November 2024, the MHRA
On November 20, 2024, the Federal Communications Commission (the “Commission”) issued a Second Report and Order in which it adopted rules (“the Order”) to facilitate the transition to from Dedicated Short Range Communications (“DSRC”) technology to Cellular-Vehicle-to-Everything (“C-V2X”) technology for the Intelligent Transportation System (“ITS” also referred to as the “connected vehicle ecosystem”). Notably, the
The European Medicines Agency (EMA) has announced that it will expand its activities under its clinical data publication policy (CDP Policy, also known as Policy 0070) to cover all clinical data submitted under new marketing authorization applications (MAAs) for medicinal products as well as any applications for line extensions or new indications, or where the
On November 14, 2024, GAO released its Bid Protest Annual Report to Congress for Fiscal Year 2024, which provides bid protest statistics and other interesting information regarding GAO’s protest system.
At the end of his prior administration, President Trump tried to overhaul the federal workforce by making it easier to remove a substantial number of federal employees. With his incoming administration, President-elect Trump may try to do so again. Though Presidents have broad authority over federal employees, these renewed efforts may face new legal challenges
November 25, 2024, Covington Alert
The inauguration of President Trump on January 20 is expected to bring important changes to U.S. trade policy that are likely to affect companies that supply international customers, or are reliant on global supply chains. As discussed in our prior client alert, international trade is expected to be a key
On October 16, 2024, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the Federal Bureau of Investigation (“FBI”) published guidance on Product Security Bad Practices (the “Guidance”) that identifies “exceptionally risky” product security practices for software manufacturers. The Guidance states that the ten identified practices—categorized as (1) Product Properties, (2) Security Features, or (3)
The Supreme Court recently granted certiorari in Cunningham v. Cornell University to address the pleading standard for prohibited transactions under the Employee Retirement Income Security Act of 1974 (“ERISA”), 29 U.S.C. § 1106(a)(1)(C).
In a putative consumer data breach class action, a court in the Northern District of California recently denied a cloud solution company’s motion to dismiss the plaintiffs’ negligence claim finding that the plaintiffs plausibly alleged that the company owed consumers a duty of care. See In re Accellion, Inc. Data Breach Litig., 2024 WL 4592367
The Court of Appeal for Ontario dismissed Binance’s appeal after a lower court declined to stay a proposed class action and enforce an arbitration agreement contained in Binance’s terms and conditions. The decision carries implications for companies who do retail business or distribute products in multiple jurisdictions, including in Canada.
Background
As a Cayman Islands