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DATE SUBMITTEDTRANSMITTAL OF ANNUAL REPORTS FOR DRUGS
AND BIOLOGICS FOR HUMAN USE
(21 CFR 314.81)NOTE: This report is required by law (21 USC 355; 21 CFR 314.81). Failure to report can
result in withdrawal
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Biologics for human are products that are made from living organisms or contain components of living organisms.
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Information such as product composition, manufacturing process, and clinical data must be reported on biologics for human.
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