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Report finds mismatch in FDA, NIH stem cell line standards - from ORCA Board Member, Erica C. Jonlin, PhD
A new report shows that many National Institutes of Health-registered stem cell lines used by academics are not fit for commercial use as the donors were not screened for various diseases, which is an FDA requirement for human-derived products. The author, Erica Jonlin, notes the FDA could make an exception to allow clinical use of the federally funded stem cells. The agencies could allow testing of the cell lines, instead of the donors -- a costly move -- to address the mismatch in the NIH and FDA standards, she said. Find more at The Scientist online (02/06/14)
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April 16, 2014
Design Input – Designing the ‘Right’ Device