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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Center for Biologics Evaluation and ResearchPublication Clearance Request Use for the review of any FDA related Article or Speech*
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Form FDA 3798 is a publication used by the Food and Drug Administration (FDA) for reporting information related to the use of certain pharmaceutical and biological products.
Manufacturers, importers, and distributors of certain pharmaceuticals and biological products are required to file Form FDA 3798.
To fill out Form FDA 3798, follow the instructions provided on the form, ensuring all relevant fields are completed accurately, including product details and company information.
The purpose of Form FDA 3798 is to collect necessary information to ensure compliance with FDA regulations regarding the safety and efficacy of pharmaceutical and biological products.
Information reported on Form FDA 3798 includes product identifiers, manufacturer and distributor details, and any relevant adverse event reports.
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