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GUIDANCE DOCUMENT

Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application Guidance for Industry November 2010

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-D-0533
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

In November 2009, we, FDA, issued a draft guidance entitled "Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus", dated November 2009 (Pandemic (H1N1) 2009 Virus Draft Guidance) (November 19, 2009, 74 FR 59982). This guidance finalizes that draft guidance. Note that while the recommendations that FDA is finalizing were proposed in the Pandemic (H1N1) 2009 Virus Draft Guidance, the finalized recommendations are applicable regardless of the existence of a pandemic or other emergency situation.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0533.

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