12/23/2014
FDA Draft Guidance: Minimal Manipulation of HCT/Ps
This email is to alert you that the availability of a draft guidance from the FDA, "Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products," was published in the December 23, 2014, Federal Register. The text of the guidance may be found by clicking here. View/download the Federal Register notice here.
This guidance is not final and is currently open for public comment. Entities involved in the manipulation of HCT/Ps should read the guidance and determine for themselves the applicability of the guidance to their programs.
