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Disclosure Requirements › Securities Litigation › Regulatory Requirements

Skadden, Arps, Slate, Meagher & Flom LLP

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

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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

Morrison & Foerster LLP

Sec Lit IQ: MoFo’s Quarterly Federal Securities Litigation and Delaware Corporate Litigation Newsletter (Q2 2025)

Morrison & Foerster LLP on

In our latest edition of MoFo’s quarterly federal securities and Delaware corporate litigation newsletter, we provide a rundown of select developments from the second quarter of 2025. The SEC’s New Crypto Guidance- On July...more

Latham & Watkins LLP

Recent Developments for Directors July 2025

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The D&O insurance market has become more favorable for insureds, with many insurers competing for placements, allowing enterprising companies and their counsel to negotiate expanded coverage and policy enhancements....more

King & Spalding

FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come

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On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...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

Eversheds Sutherland (US) LLP

SEC ends defense of climate disclosure rules

Eversheds Sutherland (US) LLP on

On March 27, 2025, the Securities and Exchange Commission (SEC) voted to end its defense of its Enhancement and Standardization of Climate-Related Disclosures for Investors rules in the ongoing Eighth Circuit case Iowa v....more

Akin Gump Strauss Hauer & Feld LLP

SEC Seeks to Pause Litigation Over Climate Disclosure Rule

Akin Gump Strauss Hauer & Feld LLP on

Earlier this week, Mark Uyeda, the Acting Chairman of the U.S. Securities and Exchange Commission (SEC), began the process of unwinding that agency’s final climate disclosure rule enacted during the Biden administration. In a...more

Sullivan & Worcester

2024 Investment Adviser Regulatory and Compliance Annual Letter

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In 2024, investment advisers – those registered with the U.S. Securities and Exchange Commission (SEC) and those that file notices as exempt reporting advisers - will continue to feel the impact of the SEC’s recent rule...more

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