Get Fda 1571 2019-2026

Filing an Investigational New Drug Application (IND) using Form FDA 1571 is a crucial step in the clinical investigation process. This guide provides clear and comprehensive instructions on how to complete the FDA 1571 form online, ensuring that you efficiently address each required section.

Follow the steps to fill out the FDA 1571 effectively.

1. Click ‘Get Form’ button to obtain the form and open it in your preferred editor.
2. Begin with section 1, entering the name of the sponsor accurately. This is the individual or organization responsible for the drug application.
3. In section 2, input the submission date using the format mm/dd/yyyy. Ensure this date is accurate as it may be referenced in future communications.
4. Section 3 requires the sponsor's address. Fill in the address fields completely, including address 1, address 2 (if applicable), city, state/province/region, country, and ZIP or postal code.
5. Section 4 asks for a telephone number, including the country code and area code if applicable. Make sure the number is up to date for any follow-ups.
6. In section 5, provide the drug name, including all available names such as trade, generic, and chemical. If there are additional names, use the continuation page.
7. Section 6A requests the IND number if one has been previously assigned. If this is a new application, you may leave this blank.
8. For section 6B, indicate whether the submission is for a commercial or research purpose by selecting one of the options provided.
9. In section 7A, state the proposed indication for use of the drug. If applicable, address whether this indication is for a rare disease.
10. Section 7B requests the SNOMED CT indication disease term. If there are additional indications, continue on a separate page.
11. Indicate the phase of clinical investigation you will conduct in section 8. This could be Phase 1, Phase 2, Phase 3, or another phase, which should be specified.
12. Section 9 requires a list of all previously submitted Investigational New Drug Applications, New Drug Applications, Drug Master Files, and Biologics License Applications referred to in this application.
13. Assign a serial number for this submission in section 10, starting with ‘Serial Number: 0000’ for the initial submission.
14. In section 11, select all relevant items that apply to this submission, such as Initial IND, Annual Report, or other specified options.
15. Section 12 asks if the product is a combination product and requires an answer to facilitate regulatory compliance.
16. In section 15, indicate if any part of the clinical study will be conducted by a contract research organization, and disclose any obligations transferred.
17. Sections 16 and 17 require names and titles of responsible persons monitoring the investigations and evaluating safety information.
18. Provide your name and title in section 18 and complete the contact details including the email address for correspondence.
19. In section 23, enter the date of the sponsor’s signature using the mm/dd/yyyy format.
20. Complete any required sections for the countersigner if applicable and ensure all signatures are provided where requested.
21. Lastly, review all entries for accuracy and completeness. Once done, you can save changes, download the form, print it for records, or share it as needed.

Complete your FDA 1571 form online today to ensure a smooth submission process.