3 Feb 2025
💊FDA Biosimilars User Fee Program
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars 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
$$ - Med
The content outlines compliance and regulatory requirements applicable to businesses in the biosimilars market, particularly regarding user fees, application processes, and patent infringement notifications. This is important for business owners and executives involved in the development of biosimilars, as they must adhere to detailed reporting and fee structures established by the FDA.