Proceedings of the Food and Drug Administration's public workshop on new red blood cell product regulatory science 2016
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.
Document Details
- Document Type
- Pub Defense Publication
- Publication Date
- Dec 15, 2017
- Source ID
- 10.1111/trf.14435
Entities
People
- Abdu I. Alayash
- Alan Doctor
- Angelo D'Alessandro
- Bernhard Palsson
- Charles Natanson
- Harold M. Swartz
- Harvey Klein
- James C. Zimring
- Jaroslav G Vostal
- Jason P. Acker
- Jennifer A. Muszynski
- John R Hess
- John W. Weisel
- Marcos Intaglietta
- Michael A. Dubick
- Michael P. Busch
- Monique P Gelderman
- Paul M. Ness
- Paul W. Buehler
- Philip C Spinella
- Philip J Norris
- Rakesh P. Patel
- Simone A. Glynn
- Sylvain Cardin
- Thomas J. Raife
- Timothy J. Mcmahon
Organizations
- Blood Systems Research Institute
- Canadian Blood Services
- Center for Systems Biology
- Dartmouth College
- Duke University Hospital
- Food and Drug Administration
- Johns Hopkins University
- National Heart, Lung, and Blood Institute
- National Institutes of Health
- National Institutes of Health Clinical Center
- Ohio State University
- United States Army Institute of Surgical Research
- United States Department of Defense
- United States Department of Health and Human Services
- University of Alabama
- University of California, San Diego
- University of Colorado
- University of Pennsylvania
- University of Washington
- University of Wisconsin–Madison
- Vitalant
- Washington University in St. Louis