Transcription of Guidance for Industry - Food and Drug Administration
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Guidance for Industry - Food and Drug Administration
Guidance for Industry Requalification Method for Reentry of Blood Donors Deferred because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc) Additional copies of this Guidance are available from the Office of Communication, Outreach and Development (OCOD) (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852 1448, or by calling 1-800-835-4709 or 301-827-1800, or email or from the Internet at For questions on the content of this Guidance , contact OCOD at the phone numbers listed above. Department of Health and Human Services food and drug Administration Center for Biologics Evaluation and Research May 2010 Contains Nonbinding Recommendations Table of Contents I. 1 II. BACKGROUND .. 2 III. 5 IV. IMPLEMENTATION .. 6 V. 7 9 i Contains Nonbinding Recommendations Guidance for Industry Requalification Method for Reentry of Blood Donors Deferred because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc) This Guidance represents the food and drug Administration s (FDA s) current thinking on this topic.
Guidance for Industry Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B
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