federal_register: E9-27729

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E9-27729 Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus". This draft guidance provides recommendations for assessing blood donor suitability and blood product safety and maintaining blood and blood product availability in response to pandemic (H1N1) 2009 virus. It is intended for establishments that manufacture Whole Blood and blood components intended for use in transfusion and blood components intended for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes. 2009-11-19 2009 11 https://www.federalregister.gov/documents/2009/11/19/E9-27729/draft-guidance-for-industry-recommendations-for-the-assessment-of-blood-donor-suitability-blood https://www.govinfo.gov/content/pkg/FR-2009-11-19/pdf/E9-27729.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply...

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