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Ebola Virus: New FDA Guidance For Blood Collection.
Legal Eagle Eye Newsletter for the Nursing Profession
On January 10, 2017 the US Food and Drug Administration (FDA) announced the availability of a new document titled Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry.
We have this new guidance document on our website at http://www.nursinglaw.com/FDA011017.pdf
This document and FDA guidance documents on a wide variety of subjects are available directly from the FDA’s website at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
This and other FDA guidance documents make it clear that they only reflect the FDA’s current scientific thinking on a particular subject and do not create mandatory legal requirements or confer legal rights.
FEDERAL REGISTER January 10, 2017 Pages 3002 - 3004