Rockville, MD, U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2007
Resource Information
The event Rockville, MD, U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2007 represents a publication, printing, distribution, issue, release or production of resources found in University of Missouri-St. Louis Libraries.
The Resource
Rockville, MD, U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2007
Resource Information
The event Rockville, MD, U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2007 represents a publication, printing, distribution, issue, release or production of resources found in University of Missouri-St. Louis Libraries.
- Label
- Rockville, MD, U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2007
- Provider date
- 2007
17 Items that share the ProviderEvent Rockville, MD, U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2007
Context
Context of Rockville, MD, U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2007Publication of
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- Guidance for industry : "computer crossmatch" (electronic based testing for the compatibility between the donor's cell type and the recipient's serum or plasma type), (electronic resource)
- Guidance for industry : adequate and appropriate donor screening for hepatitis b : hepatitis b surface antigen (HBsAg) assays used to test donors of whole blood and blood components, including source plasma and source leukocytes, (electronic resource)
- Guidance for industry : blood establishment computer system validation in the user's facility, (electronic resource)
- Guidance for industry : cell selection devices for point of care production of minimally manipulated autologous peripheral blood stem cells (PBSCs), (electronic resource)
- Guidance for industry : class II special controls guidance document : cord blood processing system and storage container, (electronic resource)
- Guidance for industry : class II special controls guidance document : in vitro HIV drug resistance genotype assay, (electronic resource)
- Guidance for industry : considerations for plasmid DNA vaccines for infectious disease indications, (electronic resource)
- Guidance for industry : eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), (electronic resource)
- Guidance for industry : informed consent recommendations for source plasma donors participating in plasmapheresis and immunization programs, (electronic resource)
- Guidance for industry : manufacturing biological intermediates and biological drug substances using spore-forming microorganisms, (electronic resource)
- Guidance for industry : providing regulatory submissions to the Center for Biologics Evaluation and Research (CBER) in electronic format, lot release protocols, (electronic resource)
- Guidance for industry : regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) : small entity compliance guide, (electronic resource)
- Guidance for industry : toxicity grading schedule for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials, (electronic resource)
- Guidance for industry and FDA review staff : collection of platelets by automated methods, (electronic resource)
- Guidance for industry and FDA staff : class II special controls guidance document : automated blood cell separator device operating by centrifugal or filtration separation principle, (electronic resource)
- Q4B, annex 2, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, (electronic resource)
- Q4B, annex 3, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination, sub-visible particles, International Conference on Harrmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, (electronic resource)
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<div class="citation" vocab="http://schema.org/"><i class="fa fa-external-link-square fa-fw"></i> Data from <span resource="http://link.umsl.edu/resource/YjbVAXvwa24/" typeof="PublicationEvent http://bibfra.me/vocab/lite/ProviderEvent"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.umsl.edu/resource/YjbVAXvwa24/">Rockville, MD, U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2007</a></span> - <span property="potentialAction" typeOf="OrganizeAction"><span property="agent" typeof="LibrarySystem http://library.link/vocab/LibrarySystem" resource="http://link.umsl.edu/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.umsl.edu/">University of Missouri-St. Louis Libraries</a></span></span></span></span></div>
