FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: CELLULAR, TISSUE, AND GENE THERAPIES ADVISORY COMMITTEE; NOTICE OF MEETING; ESTABLISHMENT OF A PUBLIC DOCKET; REQUEST FOR COMMENTS-BIOLOGICS LICENSE APPLICATION (BLA) 125842 FROM CAPRICOR, INC. FOR DERAMIOCEL (HUMAN ALLOGENEIC CARDIOSPHERE-DERIVED CELLS)

WASHINGTON, June 29 -- Food and Drug Administration has issued a notice called: Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells).

The notice was published in the Federal Register on June 29 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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 recommendat...