Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental Biologics License Application 125586/546 From AstraZeneca AB for Andexxa (Coagulation Factor Xa (Recombinant), Inactivated -zhzo); November 21, 2024

摘要

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.