FDA

U.S. Food and Drug Administration

First Cord Blood ‘Product’ Approved by FDA

November 11, 2011

HEMACORD(TM), a umbilical cord blood product, has been approved by the Food and Drug Administration for allogeneic hematopoietic stem cell transplantation, the first such approval of a stem cell product in the world. “The use of cord blood hematopoietic progenitor cell therapy offers potentially life-saving treatment options for patients with these types of disorders,” said [...]

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Breast milk sharing? Trend worries FDA

December 6, 2010

Breast milk sharing? Trend worries FDA. http://ow.ly/3kVVb http://fb.me/yWIBJMWM

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FDA Guidance to the Cord Blood Industry on CPD

April 21, 2010

In its latest guidance to the cord blood industry the FDA has recommended that cord blood banks  use only citrate-based anticoagulants (CPD) in their transport storage containers.  FamilyCord exclusively uses CPD in its state of the art collection kit. Guidance for Industry Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified [...]

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Cord Blood Bank and FDA Regulations

March 26, 2010

American Association of Tissue Banks (AATB) 14th Annual Spring MeetingMonday, March 22, 2010 Eddie Jacildo, MT(ASCP)DLM, CQA(ASQ), Director of Laboratory Operations, California Cryobank Stem Cell Services (FamilyCord) Los Angeles, CA This session discussed the current regulations affecting cord blood banks in the U.S. This session also addressed accreditation of cord blood banks and Standards that [...]

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