RE: IXJCKET NO. 2004D44$2, Comments for Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluations of Oxygen Therapeutics as Red Blood Substitutes
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چکیده
Hemosol has been one of the pioneering leaders working since 1985 in an effort to bring to market a human hemoglobin based oxygen therapeutic which would serve several important clinical needs. Hemosol welcomes the publication of this most current Guidance document as a timely response to many major developments in this field in the past near-decade. Below Hemosol first offers some general comments to the Guidance document, and these are followed by section specific comments.
منابع مشابه
Oxygen therapeutics: pursuit of an alternative to the donor red blood cell.
CONTEXT There is no true substitute for the many functions of human red blood cells, and synthetic products will not replace the need for blood donation in the foreseeable future. Hemoglobin-based oxygen carriers have many characteristics that would serve as a useful adjunct to red cells in clinical settings. Over time, these technologies have the potential to dramatically reshape the practice ...
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