💊FDA Workshop on Advancing Development of Interchangeable Products
Advancing the Development of Interchangeable Products: Identifying Future Needs; Public Workshop; Request for Comments
Summary
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Advancing the Development of Interchangeable Products: Identifying Future Needs." The purpose of the public workshop is to address a commitment FDA made in the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years (FYs) 2023 through 2027 (BsUFA III) to hold a scientific workshop to discuss and identify future needs (e.g., guidance, research) that, when addressed, may help further advance the development of interchangeable biosimilar products.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The notice relates to a public workshop by the FDA aimed at advancing development in biosimilar products, impacting compliance and regulatory requirements for businesses in the biotechnology and pharmaceutical industries. Companies that participate can influence future guidelines, addressing their development needs.