BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
March 1, 2014
May 16, 2019
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