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Mission Statement
ISCT is the global forum and resource for developing and supporting innovative cellular therapies through communication, education, and training, thus furthering clinical based investigation for the benefit of patients.
Established in 1992, the Society provides a global forum for:
Communication, education and training;
Performance of collaborative scientific studies;
Development and validation of standardized technology;
Representation of the membership to other professional organizations and regulatory and governmental bodies.
Congratulations to John Davis, The John Goldman Centre for Cellular Therapy, London, UK the Apple ITouch winner for the ISCT member renewal draw!
RENEW or JOIN ISCT NOW!
The United States Consensus Standard for the Uniform Labeling of Cellular Therapy Products using ISBT 128 Version 1.1.0 has been published. It is the result of the collaborative efforts of AABB, ASBMT, ASFA, FACT, ICCBBA, ISCT, and NMDP. Please click here to access this document.
FDA Draft Guidance Document Released on March 26, 2009:
Use of Serological Tests to Reduce the Risk of Transmission of Trypanasoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products
This guidance applies to establishments that make donor eligibility determinations for HCT/P donors. According to the FDA draft document “we are notifying you that we have determined T. cruzi to be a relevant communicable disease agent under 21 CFR 1271.3(r)(2), and are providing you with recommendations for testing and screening donors for antibodies to T. cruzi”.
The FDA is welcoming comments to this document, from the public, until June 24, 2009. For further information related to submission of comments, reference docket number FDA-2009-D-0137.
14th Annual Meeting Plenary Session CDs Now Available! Miss the meeting? Audio and presentation slides of plenary sessions available on CD.
Please be advised of a revised FDA rule, Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals, (FDA Docket # FDA-2007-N-0379) has been revised. If you manufacture licensed Biologics or Drugs, these changes may apply to your operations.
Major changes include, but are not limited to:
Aseptic processing
The use of asbestos filters
Verification of work when the primary function is performed by automated equipment