1999
FDA publishes guidance on the submission of chemistry, manufacturing and controls, and establishment description information for human blood and blood components intended for transfusion or for further manufacture and for the completion of the Form FDA 356h "Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use."
1998
1/20/98
FDA publishes a request in the Federal Register for clinical and nonclinical laboratory data and other relevant information to support the development of licensing standards for unrelated, allogeneic cord blood stem/progenitor cells for hematopoietic reconstitution.