• Last week, FDA announced the availability of a draft guidance for industry entitled, “Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271.” The draft guidance document provides certain establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), regulated solely under the Public Health Service Act and under FDA regulations, with recommendations and relevant examples for complying with the requirements to report HCT/P deviations.
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