Get Ind Application Example

Filling out the Ind Application Example online can be a straightforward process if you follow the necessary steps and guidelines. This guide will provide you with comprehensive instructions to ensure accurate completion of the form.

Follow the steps to complete the application successfully.

1. Press the ‘Get Form’ button to access the Ind Application Example and open it in the designated editor.
2. Begin by entering the investigator-sponsor’s name and academic department at the top of the form. Ensure you provide complete and accurate contact information.
3. Specify the mailing address for the Food and Drug Administration. Refer to your acknowledgement letter from the FDA to ensure that you provide the correct address.
4. In the section labeled 'Re:', include the subject of your letter, which is the IND inactivation request, along with the IND number and the name of the drug.
5. Address the letter to the specified FDA contact person by their name.
6. Include a statement confirming that you have attached three copies of the request to inactivate the IND, specifying the drug name and the date.
7. Notify that all investigators have been informed and all clinical drug supplies have been recalled or destroyed as required.
8. If applicable, include the final report for the protocol, detailing the completion status, reasons for study termination, and any relevant summary information.
9. Review the section on the IND final report, ensuring you provide individual clinical study information, summary investigational drug information, and any outstanding FDA business.
10. Finally, check the document for clarity and accuracy, then save your changes, download the completed document, and print or share it as needed.

Complete your Ind Application Example online today and ensure compliance with your submission requirements.