FDA Publishes Warning Regarding Donor Blood Plasma Treatments
On February 19th, 2019, FDA commissioner Scott Gottlieb, M,D. issued a statement regarding the clinical use of donor blood plasma for therapeutic and anti-aging purposes. FDA states: "Our concerns regarding treatments using plasma from young donors are heightened by the fact that there is no compelling clinical evidence on its efficacy, nor is there information on appropriate dosing for treatment of the conditions for which these products are being advertised". Dr. Gottlieb goes on to say: " The administration of plasma for indications other than those recognized or approved by the FDA should be performed by a qualified investigator or sponsor who has an active Investigational New Drug (IND) application with the FDA. Clinical studies are performed under an IND to help ensure the safety of participants in the trials. When clinical trials are not conducted under an IND, it means that the FDA has not reviewed the experimental therapy to help make sure it is reasonably safe."
The full FDA statement can be be viewed here.
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