12/23/2014

FDA Draft Guidance: Minimal Manipulation of HCT/Ps

FDA Draft Guidance: Minimal Manipulation of HCT/Ps 

This email is to alert you that the availability of a draft guidance from the FDA, "Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products," was published in the December 23, 2014, Federal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.  

Other Sites of Interest

Clients Logo
Clients Logo
Clients Logo
Clients Logo
Clients Logo
Clients Logo
Clients Logo