5 May 2025
💊FDA's Generic Drug User Fee Program Information Collection Overview
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Drug User Fee 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
$$ - Med
The content pertains to the Generic Drug User Fee Program, highlighting compliance and regulatory requirements affecting pharmaceutical businesses. It outlines the information collection process crucial for maintaining operations and tracking user fees. This has financial implications as businesses are required to submit specific information and fees to the FDA.