Department of Health and Human Services July 9, 2018 – Federal Register Recent Federal Regulation Documents
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Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry.'' The guidance document provides blood establishments that collect Whole Blood and blood components with revised recommendations to reduce the risk of transmission of Zika virus (ZIKV) by blood and blood components. The guidance does not apply to the collection of Source Plasma. The guidance announced in this notice supersedes the document of the same title dated August 2016 (August 2016 Guidance).
Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Indications and Usage Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' This guidance is intended to assist applicants in writing the Indications and Usage section of labeling. The recommendations in this draft guidance are intended to help ensure that the labeling is clear, concise, useful, and informative and, to the extent possible, consistent in content and format within and across drug and therapeutic classes.
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