📋FDA Adverse Event Reporting
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program
Summary
The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with FDA's adverse event reports and product experience reports for FDA-regulated products.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The content outlines regulatory requirements for businesses related to FDA's adverse event reporting, including compliance obligations for submissions of adverse event reports, which could drive operational changes to ensure adherence. The 60-day comment period also indicates potential shifts based on stakeholder feedback.