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But we are aware that the nation's blood supply is currently at a critically low level, and we know what the impact of asking for these products to be withdrawn or discontinued would be and that was certainly included in our considerations, and we are still concerned about the lack of safety and efficacy studies that have been submitted to CDER for these products.But because of the lack of adverse events reported during the long time that freezing has been performed in blood banks, and in the best interests of maintaining an adequate blood supply, blood centers may continue to freeze products in anticoagulants that are not specifically approved for this use.The title of that information sheet is FDA current thinking on irradiating and/or freezing blood components collected and stored in anticoagulant/preservative solutions not specifically approved for such use.Judy, just for the record, I don't have a financial conflict of interest but I represent a group that has had a license application in for six years and probably has the largest repository of frozen red blood cells of any other organization.Ones glow-in-the-dark s universal drugstore canada no half grooming.
But we were hoping that blood centers would submit data to us, retrospective data on the products that are currently on the market, currently being frozen, and they could provide some data to allow us to license these products officially.
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I am going to describe how this issue came to light; give you some background information to explain the scope of the problem; let you in on what we discussed to develop our current thinking and then go over our current thinking.
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