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ADDRESS Street City State and Zip code FAX NUMBER MAILING ADDRESS / PHONE NUMBERS if different from above Phone number FAX number TYPE OF APPLICATION FDA REGISTRATION NUMBER LICENSE NUMBER Original Application Resubmission of Application Supplemental Application As a Medicated Feed Mill Licensee you have certified that. Complying with all other applicable provisions of the Act. I CERTIFY that all of the statements made in this application are tru...
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Individuals or businesses involved in importing or exporting regulated products or substances may need to fill out form FDA 3448. This includes manufacturers, distributors, and importers.
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Form FDA 3448 is a form used to report adverse events or reactions related to drugs, biologics, medical devices, and dietary supplements to the U.S. Food and Drug Administration (FDA).
Manufacturers, packers, and distributors of drugs, biologics, medical devices, and dietary supplements are required to file form FDA 3448.
To fill out form FDA 3448, you need to provide information such as product details, adverse event description, patient information, and submit it electronically through the FDA's Electronic Submissions Gateway (ESG) or the FDA Adverse Event Reporting System (FAERS). Specific instructions can be found on the FDA's website.
The purpose of form FDA 3448 is to collect information on adverse events or reactions associated with drugs, biologics, medical devices, and dietary supplements. This information helps the FDA monitor the safety and efficacy of these products.
Form FDA 3448 requires the reporting of information such as product details (name, strength, dosage form, etc.), adverse event description, patient information (age, gender, weight, etc.), and contact information of the reporter. Additional information, such as medical history and concomitant medications, may also be requested.
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