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2010-09-23
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Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome or Exposure to Severe Acute Respiratory Syndrome; Availability
Notices
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United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS,'' dated September 2003. The guidance provides revised recommendations to blood establishments for assessing donor suitability and blood product safety with respect to SARS. The guidance document applies to Whole Blood and blood components intended for transfusion (including red blood cells for immunization) and blood components including recovered plasma, Source Leukocytes and Source Plasma intended for use in further manufacturing into injectable products or noninjectable products. The guidance announced in this document supersedes the document entitled ``Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS,'' dated April 2003.
68 FR 54734
https://www.govinfo.gov/app/details/FR-2003-09-18/03-23890
03-23890
fr18se03-65
4160-01-S
Docket No. 2003D-0163
https://www.govinfo.gov/app/details/FR-2003-09-18/03-23890
https://www.govinfo.gov/content/pkg/FR-2003-09-18/html/03-23890.htm
https://www.govinfo.gov/content/pkg/FR-2003-09-18/pdf/03-23890.pdf
2 p.
54734
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68 FR 54734
Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome or Exposure to Severe Acute Respiratory Syndrome; Availability; Federal Register Vol. 68, Issue
NOTICE
03-23890
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 2003D-0163
4160-01-S
03-23890
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS,'' dated September 2003. The guidance provides revised recommendations to blood establishments for assessing donor suitability and blood product safety with respect to SARS. The guidance document applies to Whole Blood and blood components intended for transfusion (including red blood cells for immunization) and blood components including recovered plasma, Source Leukocytes and Source Plasma intended for use in further manufacturing into injectable products or noninjectable products. The guidance announced in this document supersedes the document entitled ``Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS,'' dated April 2003.
Submit written or electronic comments on agency guidances at any time.
Valerie A. Butler, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827- 6210.
Reports and guidance documents; availability, etc.:
Donor suitability and blood product safety in cases of suspected severe acute respiratory syndrome or exposure to SARS; assessment recommendations,
http://www.fda.gov/cber/guidelines.htm
http://www.fda.gov/dockets/ecomments
http://www.fda.gov/ohrms/dockets/default.htm
Federal Register
Vol. 68, no. 181
Office of the Federal Register, National Archives and Records Administration
2003-09-18
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158 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-2003-09-18
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https://www.govinfo.gov/app/details/FR-2003-09-18
https://www.govinfo.gov/content/pkg/FR-2003-09-18/pdf/FR-2003-09-18.pdf
https://www.govinfo.gov/content/pkg/FR-2003-09-18/xml/FR-2003-09-18.xml
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2010-09-23
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FR-2003-09-18
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