Regulatory Requirements, Compliance
17 Jan 2025
regulatory compliance, healthcare, reporting, fda, adverse events, food and drug, submission guidelines
📋FDA Adverse Event Reporting
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.
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