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  1. NLM Digital Collections - 12/14/1984-7/25/1985 
    https://resource.nlm.nih.gov/101637321X23
    ... package insert (circular of information) for blood and blood components intended ... manufacture. An acceptable container statement is “Non-reactive by ...
  2. NLM Digital Collections - Biological product deviation reporting for blood and plasma establishments 
    Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, March 2020
    resource.nlm.nih.gov/101772639
    ... or in vitro diagnostic (IVD) manufacturer that manufactures Source Plasma or other blood components for further manufacture into another licensed biological product (e.g., Immune Globulin Intravenous (Human), Reagent Red Blood Cells), you are subject to ...
  3. NLM Digital Collections - 1985 Mar 11 
    https://resource.nlm.nih.gov/101647507X188
    ... package insert (circular of information) for blood and blood components intended ... manufacture. An acceptable container statement is “Non~reactive by ...
  4. NLM Digital Collections - AIDS Tracer M, 4/8/1985-7/18/1985 
    https://resource.nlm.nih.gov/101637321X24
    ... great concern within the Department of Health and Human Services, the blood bank ... nto blood derivatives. The letters contained recommendations to ...
  5. NLM Digital Collections - Alternative procedures for blood and blood components during the COVID-19 public health ... 
    Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, April 2020
    resource.nlm.nih.gov/9918227367106676
    ... U.S. blood supply, including collections of blood and blood components for transfusion and collections of Source Plasma for further manufacture into plasma derivatives. As the COVID-19 pandemic ...
  6. NLM Digital Collections - Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in ... 
    Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2017
    resource.nlm.nih.gov/101720003
    ... and blood components. These recommendations apply to the collection of blood ... to manufacture, a medical device. FDA previously issued the following ...
  7. NLM Digital Collections - Nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C ... 
    Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2017
    resource.nlm.nih.gov/101719989
    ... of Whole Blood or blood components, including Source Plasma and Source ... products (except if pooled). You must notify transfusion recipients ...
  8. NLM Digital Collections - Chemistry, manufacturing, and control (CMC) information for human gene therapy ... 
    Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
    resource.nlm.nih.gov/101767656
    ... ensure that no recalled lots were used during manufacture or preparation of the ... at FDA licensed facilities. Source Plasma, which is often used to make human ...
  9. NLM Digital Collections - 4/27/1982-6/24/1983 
    https://resource.nlm.nih.gov/101637321X3
    ... AIDS) from Plasma Donors TO: All Establishments Collecting Source Plasma (Human) ... in plasna collection have reached a consensus as to appropriate steps ...
  10. NLM Digital Collections - 7/1/1983-9/15/1983 
    https://resource.nlm.nih.gov/101637321X6
    ... AIDS) from Plasma Donors TO: All Establishments Collecting Source Plasma ... in plasma collection have reached a ' Consensus as to appropriate steps ...
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