1 May 2025
💊FDA Notice on Prescription Drug User Fee Program Details
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug User Fee Program
Summary
The Food and Drug Administration (FDA, Agency, or we) 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 the Prescription Drug User Fee Program (PDUFA), detailing compliance requirements and fees pharmaceutical companies must pay for drug approval processes. These financial obligations can directly affect operating costs and funding strategies for businesses in the pharmaceutical industry.