Get Form Fda 3674. Certification Of Compliance Under 42 U.s.c.282(j)(5)(b), With Requirements Of

Filling out the FORM FDA 3674 is essential for compliance under U.S. law regarding clinical trials and applications. This guide provides step-by-step support for accurately completing the form online.

Follow the steps to complete the form correctly.

1. Click ‘Get Form’ button to obtain the form, then open it in your preferred editing platform.
2. Enter the name of the sponsor, applicant, or submitter in the first section of the form. Ensure that the name is complete and accurate.
3. Fill in the date of the application or submission to ensure proper documentation.
4. Provide contact information in the telephone and fax number fields, including country and area codes as necessary.
5. Complete the address fields with the physical location, making sure to include any additional details like apartment or suite numbers.
6. In the product information section, specify the relevant name(s) of drugs, biologics, or devices included in your submission.
7. Select the type of application or submission that this certification accompanies from the options provided.
8. If applicable, provide any assigned numbers related to the application or submission, including IND, NDA, ANDA, or any other relevant identifiers.
9. In the certification statement section, choose the appropriate box that reflects your compliance status with the requirements under the applicable U.S. code.
10. If you indicated box C in step 9, list the National Clinical Trial (NCT) numbers of the trials for which you are the responsible party.
11. The undersigned will then provide their name, title, and contact information in order to validate the submission.
12. Sign and date the certification to confirm the accuracy and completeness of the provided information.
13. Once all sections are completed, save your changes, download the document, print, or share it as needed.

Complete your document online today to ensure compliance and support your submission process.