On February 8-9, 2017 the Food and Drug Administration (FDA) organized a public workshop entitled ‘Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products’. The purpose of this workshop was to...

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The US Food and Drug Administration (FDA) recently released the final version of the guidance document about nonproprietary naming of biological products. This long awaited document applies to originator biological products, related biological products and biosimilars...