CDRH/CBER combo product reviews
This article was originally published in The Gray Sheet
Joint tissue review group begins exploring possible pilot initiatives. The group, announced in June, was created to facilitate the review of tissue-based products with device components. Separately, the name for the Biological Response Modifiers Advisory Committee has been changed to the Cellular, Tissue & Gene Therapies Advisory Committee. The new name "more accurately describes the subject areas for which the committee is responsible," FDA explains...
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