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Form Approved: OMB No. 09100498; Expiration Date: 4/30/2024Department of Health and Human Services
Food and Drug AdministrationSUPPLEMENTARY INFORMATION
CERTIFICATE OF A PHARMACEUTICAL PRODUCTS end
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Who needs form fda-3613b?
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What is form fda-3613b?
Form FDA-3613B is a submission form used by entities to report certain information to the U.S. Food and Drug Administration (FDA) concerning drugs and biologics that may affect public health.
Who is required to file form fda-3613b?
Entities involved in the manufacturing, distribution, or marketing of drugs and biologics, as well as those involved in clinical trials, are required to file Form FDA-3613B.
How to fill out form fda-3613b?
To fill out Form FDA-3613B, provide the required information as prompted in the form, including but not limited to details about the product, the company, and specific regulatory information.
What is the purpose of form fda-3613b?
The purpose of Form FDA-3613B is to ensure that the FDA receives critical information related to the safety and efficacy of drugs and biologics, facilitating regulatory oversight and public health protection.
What information must be reported on form fda-3613b?
Form FDA-3613B requires reporting information such as the identity of the product, the manufacturer, production methods, labeling, and any safety or efficacy data.
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