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Transfusion. 2018 Jan;58(1):255-266. doi: 10.1111/trf.14435. Epub 2017 Dec 15.

Proceedings of the Food and Drug Administration's public workshop on new red blood cell product regulatory science 2016.

Author information

1
Division of Blood Components and Devices, OBRR, CBER, Food and Drug Administration, Silver Spring, Maryland.
2
Department of Pediatric Critical Care, St Louis Children's Hospital, St Louis, Missouri.
3
Puget Sound Blood Center, Seattle, Washington.
4
Division of Blood Diseases and Resources, NHLBI, NIH, Bethesda, Maryland.
5
Department of Laboratory Medicine and Hematology, University of Washington, School of Medicine, Seattle, Washington.
6
Department of Transfusion Medicine, National Institutes of Health, Clinical Center, Bethesda, Maryland.
7
Department of Research & Development, Canadian Blood Services, Edmonton, Alberta, Canada.
8
Department of Pediatric Critical Care, Washington University School of Medicine, St Louis, Missouri.
9
Department of Biochemistry and Molecular Genetics, University of Colorado-Anschutz Medical Campus, Denver, Colorado.
10
Center for Systems Biology, University of Iceland, Reykjavik, Iceland.
11
Department of Pathology and Laboratory Medicine, University of Wisconsin-Madison, Madison, Wisconsin.
12
Blood Systems Research Institute, San Francisco, California.
13
Department of Medicine, Pulmonary, Allergy, & Critical Care Medicine, Duke University Medical Center, and the Durham VA Medical Center, Durham, North Carolina.
14
Department of Bioengineering, University of California at San Diego, San Diego, California.
15
Department of Radiology, Dartmouth College Geisel School of Medicine, Hanover, New Hampshire.
16
US Army Institute of Surgical Research, San Antonio, Texas.
17
Naval Medical Research Unit-San Antonio, San Antonio, Texas.
18
Center for Free Radical Biology and Translational and Molecular Sciences Certificate Program, University of Alabama, Birmingham, Alabama.
19
Critical Care Medicine, NIH Clinical Center, Bethesda, Maryland.
20
Cell and Developmental Biology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
21
Division of Critical Care Medicine, The Ohio State University College of Medicine, Columbus, Ohio.
22
Blood Systems Research Institute, Blood Systems, Inc., San Francisco, California.
23
Division of Transfusion Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.

Abstract

The US Food and Drug Administration (FDA) held a workshop on red blood cell (RBC) product regulatory science on October 6 and 7, 2016, at the Natcher Conference Center on the National Institutes of Health (NIH) Campus in Bethesda, Maryland. The workshop was supported by the National Heart, Lung, and Blood Institute, NIH; the Department of Defense; the Office of the Assistant Secretary for Health, Department of Health and Human Services; and the Center for Biologics Evaluation and Research, FDA. The workshop reviewed the status and scientific basis of the current regulatory framework and the available scientific tools to expand it to evaluate innovative and future RBC transfusion products. A full record of the proceedings is available on the FDA website (http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm507890.htm). The contents of the summary are the authors' opinions and do not represent agency policy.

PMID:
29243830
PMCID:
PMC6258195
DOI:
10.1111/trf.14435
[Indexed for MEDLINE]
Free PMC Article

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