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Zdrowie i gospodarka · 23.12.2014

Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff." The draft guidance document provides human cells, tissues, and cellular- and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff with recommendations for meeting the criterion of "minimal manipulation" as it applies to HCT/Ps. The draft guidance, when finalized, is intended to supersede the document entitled "Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update" dated September 2006. This draft guidance is not final nor is it in effect at this time.

Source: Federal Register — Food and Drug AdministrationOpen original release →