April 17, 2020
FDA Requests Comments On Product User Fee Programs
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 6, 2020, the U.S. Food and Drug Administration (FDA) published a report that provides options and recommendations for a new methodology to evaluate changes in resource capacity needs of human drug and biosimilar biologic review programs. Titled “Independent Evaluation of the PDUFA and BsUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations,” the analysis of the methodology was reviewed by an...