News & Analysis as of

Regulatory Requirements Final Guidance Disclosure Requirements

McCarter & English, LLP

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

Hogan Lovells

SEC staff revives former guidance on shareholder proposals raising social policy issues

Hogan Lovells on

On February 12, the SEC’s Division of Corporation Finance issued Staff Legal Bulletin No. 14M (SLB 14M) to update its guidance on the “economic relevance” and “ordinary business” exclusions in Exchange Act Rule 14a-8, which...more

Goodwin

How to (Finally) Get Your SIUU Out: FDA Issues Final Guidance on Communicating Off-Label Scientific Information

Goodwin on

On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

A&O Shearman

Regulatory monitoring - December 2024

A&O Shearman on

1. Bank regulation - 1.1 PRUDENTIAL REGULATION - a) General - (i) International - FSB: Plenary December 2024 - Status: Final - The FSB has set out the outcomes of its Plenary that met on 3 and 4 December. Points of...more

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