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Securities Litigation Regulatory Oversight Disclosure Requirements

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Pivots on Publishing Complete Response Letters, Raising SEC Disclosure and Securities Litigation Implications

On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more

Paul Hastings LLP

SEC Commissioner Paul Atkins Promises Increased Enforcement of US-Listed Chinese Companies

Paul Hastings LLP on

During Securities and Exchange Commission Chairman Paul Atkins’ Senate confirmation hearing, a lawmaker asked him, “Would [you] investigate Chinese companies for … wanton and blatant violations of U.S. disclosure laws that...more

Hogan Lovells

FDA’s creation of public database of 200 Complete Response letters raises questions

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more

Patterson Belknap Webb & Tyler LLP

Increase in Securities Litigation and Regulatory Scrutiny Concerning Artificial Intelligence

Several recent lawsuits, and comments by the U.S. Securities and Exchange Commission (“SEC”) and Federal Trade Commission (“FTC”), underscore the increasing litigation and regulatory scrutiny concerning the use of artificial...more

Skadden, Arps, Slate, Meagher & Flom LLP

Investment Management Update - February 2024

In this issue, we cover regulatory developments from the fourth quarter of 2023 impacting the investment management sector, including the use of shareholder rights plans as an alternative to state control share statutes....more

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