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Disclosure Requirements › Healthcare › Regulatory Oversight

Holland & Knight LLP

FDA Announces Prompt Disclosure of Complete Response Letters, Release of Additional Letters

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) on Sept. 4, 2025, announced the release of 89 previously unpublished Complete Response Letters (CRLs), building on the previous release of more than 200 CRLs on July 10, 2025. The...more

Orrick, Herrington & Sutcliffe LLP

FDA’s “Radical Transparency” Arrives: Real-Time Publication of CRLs Poses New Exposures for Innovative Pharmaceutical Companies

Orrick, Herrington & Sutcliffe LLP on

The U.S. Food and Drug Administration (FDA) has unveiled a sweeping transparency initiative that will fundamentally change how innovative drug and biologic developers interface with the Agency and the market. ...more

Holland & Knight LLP

Proposed Changes to New York's Material Transactions Law Expand Oversight

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New York Gov. Kathy Hochul unveiled her executive budget proposal for State Fiscal Year (FY) 2025-2026 on Jan. 21, 2025, which includes amendments to the state's Disclosure of Material Transactions law. If the amendments are...more

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