If you need to reference a previous FDA submission, you may need to write a cross reference letter. This article will provide tips on how to write an effective cross reference letter and provide examples that you can edit and use for your own submissions.
A cross reference letter is a document that references a previous FDA submission. In this article, we will provide examples and tips on how to write an effective cross reference letter for your own submissions.
Tips for Writing a Cross Reference Letter FDA
Before writing your cross reference letter, it is important to have a clear understanding of the purpose of the letter. Here are some tips to help you write an effective cross reference letter for FDA submissions:
1. Cross Reference Letter for a New Submission
Dear FDA Reviewer,
I am submitting a new application for [drug/device]. I would like to reference my previous submission [submission number] for [purpose of reference]. This cross reference letter is to inform you that we have provided all the information required in the previous submission and we have made no changes to that information in this new submission.
Thank you,
[Your Name]
2. Cross Reference Letter for a Supplemental Submission
Dear FDA Reviewer,
I am submitting a supplemental application for [drug/device]. I would like to reference my previous submission [submission number] for [purpose of reference]. This cross reference letter is to inform you that we have provided all the information required in the previous submission and we have made no changes to that information in this supplemental submission.
Thank you,
[Your Name]
3. Cross Reference Letter for an Amended Submission
Dear FDA Reviewer,
I am submitting an amended application for [drug/device]. I would like to reference my previous submission [submission number] for [purpose of reference]. This cross reference letter is to inform you that we have provided all the information required in the previous submission and we have made changes to that information as outlined in the amendment.
Thank you,
[Your Name]
4. Cross Reference Letter for a Resubmitted Application
Dear FDA Reviewer,
I am resubmitting my application for [drug/device]. I would like to reference my previous submission [submission number] for [purpose of reference]. This cross reference letter is to inform you that we have provided all the information required in the previous submission and we have made changes to that information as outlined in the resubmission.
Thank you,
[Your Name]
5. Cross Reference Letter for a Withdrawn Submission
Dear FDA Reviewer,
I am writing to inform you that we have withdrawn our previous submission [submission number] for [drug/device]. This cross reference letter is to confirm that we have not included any of the information from the previous submission in this withdrawal.
Thank you,
[Your Name]
6. Cross Reference Letter for a Response to FDA Review
Dear FDA Reviewer,
I am submitting my response to your review of our previous submission [submission number] for [drug/device]. This cross reference letter is to inform you that we have addressed all of the issues raised in your review and have provided the information you requested in this response.
Thank you,
[Your Name]
7. Cross Reference Letter for a Request for Designation
Dear FDA Reviewer,
I am submitting a request for designation for [drug/device]. I would like to reference my previous submission [submission number] for [purpose of reference]. This cross reference letter is to inform you that we have provided all the information required in the previous submission and we have made no changes to that information in this request for designation.
Thank you,
[Your Name]
Frequently Asked Questions
What is a cross reference letter in FDA submissions?
A cross reference letter is a document that references a previous FDA submission. It is used to inform the FDA that you are using information from a previous submission in your current submission or to confirm that you are not using information from a previous submission.
When should I use a cross reference letter in my FDA submission?
You should use a cross reference letter when you are using information from a previous FDA submission in your current submission or when you want to confirm that you are not using information from a previous submission. This is common when you are submitting a supplemental or amended application.
Do I need to include a cross reference letter in my FDA submission?
It is not always necessary to include a cross reference letter in your FDA submission, but it can be helpful in certain situations. If you are using information from a previous submission, a cross reference letter can help the FDA understand how the information is being used in the current submission. If you are not using information from a previous submission, a cross reference letter can help confirm that you have not included that information.
How do I write a cross reference letter for FDA submissions?
To write a cross reference letter, start by identifying the previous submission you want to reference and the purpose of the reference. You should include the submission number and describe the information you are referencing. Be sure to clearly state whether you are using the information in the current submission or confirming that you are not using the information. End the letter with a thank you and your name.
Can I use a template for my cross reference letter?
Yes, you can use the examples provided in this article as a template for your own cross reference letter. Be sure to edit the examples as needed to fit your specific situation and submission.
Do I need to include a separate cover letter with my cross reference letter?
No, a separate cover letter is not necessary if you include the cross reference letter in your FDA submission. However, you may want to include a brief introduction in your cover letter to explain the purpose of the cross reference letter.
What is the purpose of a cross reference letter in FDA submissions?
The purpose of a cross reference letter is to reference a previous FDA submission and to inform the FDA how that information is being used in the current submission or to confirm that it is not being used. This can help the FDA understand the context of the current submission and make a more informed decision.
Conclusion
A cross reference letter is an important document for FDA submissions. By following the tips and examples provided in this article, you can write an effective cross reference letter that helps the FDA understand the context of your submission and make a more informed decision.