federal_register: 2019-27520

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2019-27520 Considerations for the Development of Dried Plasma Products Intended for Transfusion; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Considerations for the Development of Dried Plasma Products Intended for Transfusion; Guidance for Industry." The guidance document provides recommendations intended to assist manufacturers, sponsors, and applicants developing dried plasma products intended for transfusion in order to facilitate the availability of safe and effective dried plasma products in the United States. The guidance document provides considerations for the successful development and licensing of dried plasma products and for the approval of devices used to manufacture dried plasma. The guidance includes recommendations on optimal sources of input plasma; manufacturing and product quality, including product characterization; packaging and reconstitution; clinical studies; and device submissions. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2018. 2019-12-20 2019 12 https://www.federalregister.gov/documents/2019/12/20/2019-27520/considerations-for-the-development-of-dried-plasma-products-intended-for-transfusion-guidance-for https://www.govinfo.gov/content/pkg/FR-2019-12-20/pdf/2019-27520.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Considerations for the Development of Dried Plasma Products Intended for Transfusion; Guidance for Industry." The guidance document provides...

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