January 18, 2007
The Food and Drug Administration (FDA) has issued a draft guidance recommending a streamlined path to licensure for establishments that manufacture cord blood for certain medical conditions.
Placental/umbilical cord blood is a rich source of precursor cells capable of differentiating into mature blood cells that can be used to replenish the bone marrow in patients with blood-based malignancies such as leukemia.
The draft guidance describes the FDA’s regulatory approach to the regulation of cord blood hematopoietic stem/progenitor cells that are minimally manipulated (processing does not alter the original characteristics of the cells); used to replenish the bone marrow in patients with blood-related malignancies; and used in recipients unrelated to the donor of the stem cells.
The FDA is accepting public comment for 90 days from the date of publication in the Federal Register. Electronic comments may be sent to [removed]www.fda.gov/dockets/ecomments[/removed].
The guidance can be viewed in full [removed]online[/removed].
