Get Filling Out The Form Fda 1571: (the Numbers Below ...

Filling out the Form FDA 1571 is a crucial step in initiating a clinical investigation. This guide provides detailed, step-by-step instructions for completing the form to ensure accuracy and compliance.

Follow the steps to successfully complete the Form FDA 1571.

1. Click 'Get Form' button to access the form online and open it in your browser.
2. In the first section, enter the name of the sponsor, which can be a company or individual responsible for the investigation. Ensure that only one person is designated as the sponsor.
3. Fill in the date of submission, which is the date you are sending the application to the FDA.
4. Provide the address where FDA correspondence will be sent. If you are using a post office box, include a street address as well.
5. Input the telephone number where the sponsor can be reached during working hours.
6. List the name(s) of the drug involved in the investigation, including their generic and trade names, as well as dosage forms.
7. If applicable, enter the IND number if you have previously been assigned an emergency IND number or if this form is part of an amendment.
8. State the indication(s) for the clinical trial. Ensure that this information is clear and concise.
9. If you are a pharmaceutical firm, indicate the phase(s) of the clinical investigation on the form. This is not required for Sponsor-Investigators.
10. List the numbers of all referenced INDs, NDAs, DMFs, and PLAs, if applicable. Make sure to include necessary authorization letters, if required.
11. Consecutively number the submission, noting that this is primarily for pharmaceutical firms and not required for Sponsor-Investigators.
12. Check the relevant boxes regarding the type of information included in the submission. Only check the 'Initial Investigational New Drug Application (IND)' box for original submissions.
13. For Sponsor-Investigator INDs, ensure that items related to the investigational drug, such as manufacturing and controls, are completed thoroughly.
14. For pharmaceutical firms, enter the name of the person responsible for monitoring the clinical investigation and evaluating safety information.
15. Include the name and signature of the sponsor or their authorizing representative. If it’s a Sponsor-Investigator IND, that individual must sign the form.
16. Fill out the address and phone number fields if they differ from boxes 3 and 4; otherwise, it is optional.
17. Finally, enter the date when the form is signed by the sponsor.

Complete your Form FDA 1571 online now to ensure your clinical investigation is initiated smoothly.