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NEW PRODUCT SUBMISSION FORM APPLICANT INFORMATION Date of submission Name of applicant Physical address Postal Address First contact: Name Position Telephone number Email address Second contact: Name
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Pharmaceutical companies and manufacturers who are seeking to make changes to an approved drug product formulation or labeling may need to submit form FDA 356h supplement to the FDA for review and approval.
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What is form fda 356h supplement?
Form FDA 356h supplement is a form used to submit additional information or data to the U.S. Food and Drug Administration (FDA) regarding an approved drug or biologic.
Who is required to file form fda 356h supplement?
The manufacturers or sponsors of approved drugs or biologics are required to file form FDA 356h supplement.
How to fill out form fda 356h supplement?
Form FDA 356h supplement can be filled out electronically through the FDA's Electronic Submissions Gateway or manually by following the instructions provided on the form.
What is the purpose of form fda 356h supplement?
The purpose of form FDA 356h supplement is to provide the FDA with additional information or data related to an approved drug or biologic that was not included in the original application.
What information must be reported on form fda 356h supplement?
Form FDA 356h supplement typically requires information such as updated safety data, new clinical trial results, changes in manufacturing processes, or labeling revisions.
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