federal_register: 2016-31771

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2016-31771 Labeling of Red Blood Cell Units With Historical Antigen Typing Results; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Draft Guidance for Industry." The draft guidance document provides establishments that collect blood and blood components for transfusion with recommendations for labeling Red Blood Cell (RBC) units with non-ABO/ Rh(D) antigen typing results obtained from previous donations (historical antigen typing results). The draft guidance provides recommendations to transfusion services for managing RBC units labeled with historical antigen typing results. The guidance also provides licensed blood collection establishments that choose to implement labeling of RBC units with historical antigen typing results instructions regarding how to report the manufacturing and labeling changes under the biologics regulations. The guidance does not apply to test results for ABO and Rh(D) antigens. 2017-01-03 2017 1 https://www.federalregister.gov/documents/2017/01/03/2016-31771/labeling-of-red-blood-cell-units-with-historical-antigen-typing-results-draft-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2017-01-03/pdf/2016-31771.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Draft Guidance for Industry." The draft guidance document provides...  

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