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Form Approved: OMB No. 09100025 Expiration Date: August 31, 2023FORM FDA 3647 (09/20) Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor LampsPublic reporting burden for

How to fill out form fda 3647

How to fill out form fda 3647

1. To fill out form FDA 3647, follow these steps:
2. Begin by providing the name and address of the regulatory submission contact person.
3. Indicate the type of submission being made (e.g., new application, supplemental application, annual report).
4. Specify the product information, including the drug trade name, active ingredients, strength, and dosage form.
5. Include the submission date and the anticipated first marketing date.
6. Provide details on the labeling of the product, such as the proposed package insert, patient labeling, and carton/container labeling.
7. Fill in the manufacturing information, including the name and address of the manufacturer, packager, and distributor, as well as the manufacturing and control section.
8. Include the proposed indication, dosing, and usage instructions for the product.
9. Attach any relevant documentation or additional information that supports the submission.
10. Sign and date the form.
11. Submit the completed form FDA 3647 according to the appropriate submission process (e.g., mail, electronic submission).

Who needs form fda 3647?

1. Form FDA 3647 is needed by pharmaceutical companies and manufacturers who are submitting a regulatory application or report to the Food and Drug Administration (FDA).
2. It is required for various purposes such as new drug applications, supplemental applications, and annual reports.
3. Anyone involved in the development, manufacturing, or distribution of a drug product that is subject to FDA regulation may need to fill out this form.

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What is form fda 3647?

Form FDA 3647 is an official document used by the U.S. Food and Drug Administration (FDA) to collect information related to the use of drug and biological product manufacturing.

Who is required to file form fda 3647?

Manufacturers and distributors of drugs and biological products who are subject to FDA regulations are required to file Form FDA 3647.

How to fill out form fda 3647?

To fill out Form FDA 3647, you should provide accurate and complete information in all required fields, following the instructions provided by the FDA for the form.

What is the purpose of form fda 3647?

The purpose of Form FDA 3647 is to ensure compliance with FDA regulations by gathering pertinent information about the manufacturing and distribution of drug products.

What information must be reported on form fda 3647?

The form requires information such as manufacturer details, product description, quantities produced or distributed, and any pertinent regulatory compliance data.