Get 2253 Form Fda

Filling out the 2253 Form Fda online can seem daunting, but with the right guidance, you can complete it efficiently and accurately. This form is essential for the transmittal of advertisements and promotional labeling for drugs and biologics for human use submitted to the FDA.

Follow the steps to successfully complete the 2253 Form Fda online.

1. Click ‘Get Form’ button to obtain the 2253 Form and open it for editing.
2. In the 'Date Submitted' field, enter the date you are submitting the form and materials. Use the dropdown calendar or provide the date in MM/DD/YYYY format.
3. If applicable, provide the 'Label Review Number' from Form FDA 2567. This number is associated with your previously assigned label review.
4. Select the applicable application type from the dropdown: NDA, ANDA, AADA, BLA, or PMA. Enter the number corresponding to your application. Indicate if your submission pertains to a single product or multiple products.
5. For single products, ensure that each submission only includes one application number. For multiple products, include only one application number on the form and provide details of any additional products on a separate sheet.
6. Enter the 'Proprietary Name' of the drug or biologic, including the dosage form if applicable.
7. Provide the 'Established Name' for the product, which is the generic name.
8. Include the 'Package Insert Date' and the corresponding ID number for the most current labeling for your product.
9. Fill in the 'Manufacturer Name' and, if applicable, the license number for biological product submissions.
10. In the 'Advertising/Promotional Labeling Materials' section, list all promotional materials you are submitting line by line, including detailed descriptions.
11. Specify whether the materials are intended for 'Professional' or 'Consumer' audiences, selecting only one option.
12. For the 'Material Type,' reference the FDA codes related to different types of materials being submitted.
13. Fill in the 'Dissemination/Publication Date' using the calendar dropdown or in MM/DD/YYYY format.
14. Provide 'Material ID Code' for your promotional materials.
15. Describe each promotional material in the 'Material Description' field.
16. In the 'Comments' section, include any information relevant to the dissemination method and details about accompanying materials.
17. Add the 'Applicant (or Agent’s) Return Address,' ensuring to include the country.
18. Input the responsible official or agent's 'Telephone Number,' 'FAX Number,' and 'Email Address' in the respective fields.
19. Type the name and title of the responsible individual under 'Typed Name and Title of Responsible Official or Agent.'
20. Have the responsible official or agent sign the form in the 'Signature' field.
21. Enter the 'Date' of signature in the provided format.
22. For biological products, fill out the section for CBER products as needed.
23. Finally, review all entered data for accuracy, save your changes, and proceed to download, print, or share the form as necessary.

Complete your submission for the 2253 Form Fda online today to ensure timely processing.