Should the RBC in vivo recovery threshold value of greater than equals 75 percent be changed?
The reason we ask this question was that since 2004, after FDA institute the revised criterion, some of the manufacturers raised the concern that some of the new RBC products may not be able to meet the current acceptable criteria, and the products already on the market would not meet the criteria either. Therefore, the manufacturers volunteered to provide the RBC in vivo recovery study data used for the support and approval of RBC products already on the market, to reassess the current criterion. And Drs. Dumont and AuBuchon collected the data and analyzed the data. The objective of the BEST study was to determine if the products already on the market would be able to meet FDA’s current acceptance criteria, and the BEST study concluded that the overall data analysis from 1990 to 2006 will not meet FDA’s current acceptance criteria unless the threshold value changed from 75 percent to 67 percent. Well, FDA also analyzed the data after Dr. Dumont kindly shared the BEST data with FDA and
