Get Fda 1571 2018

Filling out the FDA 1571 form is a crucial step for sponsors seeking an investigational new drug application. This guide provides a comprehensive step-by-step approach to help users navigate the form online with clarity and confidence.

Follow the steps to successfully complete the FDA 1571 form online.

1. Click ‘Get Form’ button to obtain the FDA 1571 form and open it in your preferred online editor.
2. In the first section, enter the name of the sponsor. This should include the full legal name of the entity submitting the application.
3. Next, provide the date of submission in the format mm/dd/yyyy, ensuring accuracy to avoid processing delays.
4. Input the sponsor's address, including street address, city, state/province/region, country, and ZIP or postal code.
5. Include the sponsor's telephone number, making sure to include the country code if applicable.
6. If an IND number has been previously assigned, enter it in the designated field. If this is the first submission, leave this field blank.
7. Select whether the application is for commercial or research purposes by checking the appropriate box.
8. List the name of the drug, ensuring that all available names (trade, generic, chemical, or code) are included.
9. Describe the proposed indication for use. Determine if it is for a rare disease and indicate if there is an FDA orphan designation for it.
10. Specify the phase of clinical investigation to be conducted (Phase 1, 2, 3, or other) and provide necessary details.
11. List all relevant investigational new drug applications, new drug applications, drug master files, and biologics license applications referenced in this application.
12. Provide the initial serial number as ‘0000’ and make sure to sequentially number any subsequent submissions.
13. Indicate which items are included in this submission by selecting all that apply from the options provided.
14. Identify whether the product is a combination product and provide justification if applicable.
15. If a contract research organization will conduct any part of the study, provide the necessary details as specified.
16. Input the name and title of the person responsible for monitoring the study's progress along with their contact information.
17. Acknowledge the agreement statement regarding clinical investigations. Ensure the sponsor name, title, and contact details are correctly filled in.
18. Finalize the document by entering the sponsor's and countersigner's names, addresses, email addresses, and signatures.
19. Once all sections are completed, users can save changes, download, print, or share the form as needed.

Complete your FDA 1571 application online today to ensure compliance and streamline your submission process.