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Showing content with the highest reputation on 03/18/2018 in all areas

  1. It's very easy (and preferred by FDA) to do it online. https://www.accessdata.fda.gov/scripts/cber/CFApps/Login/Index.cfm?CFID=40907533&CFTOKEN=d53320b604cd5b33-CA2F5DED-DE8D-E592-8495BFDE2A8C4673 The form can be found here: https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/default.htm
    1 point
  2. In many ways I do agree with what you write, but, however rare K+k- individuals may be, they are considerably more common than are either Kp(b-) and Js(b-) individuals. It would seem reasonable, therefore, to test for such individuals, in the knowledge that, nationally, and, perhaps, internationally, K+k- blood can be supplied reasonably easily, whereas the search for a reasonable supply of either Kp(b-) or Js(b-) donations could prove fruitless. Again, with regard to Dombrock antibodies, although undeniably these can be clinically significant, such clinically significant antibodies are incredibly rare - so much so that they are often still written up as posters or abstracts, even in patients who are not on Dara, or similar monoclonal antibody treatment.
    1 point
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