25 Jun 2025
📋FDA Adverse Event Reporting Program
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program
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
$$$ - High
The document outlines compliance and reporting requirements for businesses in the health sector related to adverse event reporting for FDA-regulated products. It includes details about proposed modifications to reporting forms, which affect operational procedures for manufacturers and healthcare providers.