FDA & Placental/Umbilical Cord Blood Products
يدور هذا النقاش حول FDA & Placental/Umbilical Cord Blood Products في قسم آخر المستجدات الطبية في الملتقى الطبي السوري; -->
The Food and Drug Administration (FDA) today issued a draft guidance recommending a streamlined path to licensure for establishments that manufacture cord blood for certain medical conditions.
Placental/umbilical cord
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#1
Jan, 16 2007, 22:31
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 FDA & Placental/Umbilical Cord Blood Products The Food and Drug Administration (FDA) today issued a draft guidance recommending a streamlined path to licensure for establishments that manufacture cord blood for certain medical conditions.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. These precursor cells are known as hematopoietic stem/progenitor cells and can be used to replenish the bone marrow in patients with blood-based malignancies such as leukemia. The draft guidance describes FDA's regulatory approach to the regulation of cord blood hematopoietic stem/progenitor cells that are minimally manipulated (processing does not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) a used to replenish the bone marrow in patients with blood-related malignancies used in recipients unrelated to the donor of the stem cells In 2003, the agency convened its Biological Response Modifiers Advisory Committee to discuss the current clinical data, safety and effectiveness issues surrounding placental/umbilical cord blood transplantation, and possible quality measures. At that time, cord blood was being used in increasing numbers, and members of the interested public voiced their opinion that licensure of cord blood products would increase confidence in the safety and effectiveness of these products FDA has since determined that cord blood hematopoietic stem/progenitor cells are safe and effective for certain indications based on the data submitted to the public docket and the large body of published literature Therefore, the new draft guidance offers cord blood banks a less burdensome path to licensure. Rather than having to submit their own clinical data, they may cite existing data in the docket The draft guidance also provides manufacturers with recommendations on the content and format of information to be submitted with an application, discusses the manufacture of cord blood hematopoietic stem/progenitor cells and elaborates on how to comply with applicable regulatory requirements لقراءة المزيد ... راجع المصدر...  |
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