1 May 2025

📄FDA Notice on Financial Disclosure for Clinical Investigators

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators

Summary

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Agencies

  • Health and Human Services Department
  • Food and Drug Administration

Business Impact ?

$$ - Med

This notice outlines compliance requirements for financial disclosure by clinical investigators involved in FDA-regulated studies, impacting pharmaceutical and medical device companies. Sponsors must compile and submit disclosures, potentially influencing operational costs and regulatory best practices.

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