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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.
Manufacturers of biologics for human are required to file with the appropriate regulatory authorities.
Biologics for human should be filled out according to the guidelines provided by the regulatory authorities.
The purpose of biologics for human is to ensure the safety, efficacy, and quality of biologic products for human use.
Information such as product composition, manufacturing process, and clinical data must be reported on biologics for human.
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