Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) response to FDA (Docket no. 97N-0068). FAHCT Board of Directors.
Academic Article
Overview
abstract
We believe the proposed model is appropriate to our current state of knowledge and recognize that FDA regulations will evolved as the field evolves. We thank you for the opportunity to work with FDA as its regulatory strategy is developed in the near future.