If you’re submitting a new drug application, you’ll need to include the cross reference letter in your submission. This letter serves as a guide to the FDA that explains the relationship between the information in the application and the information contained in previous submissions. In this article, we’ll discuss the basics of the cross reference letter FDA and provide you with seven examples that you can use as a starting point when creating your own.
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When it comes to writing a cross reference letter, there are a few key things to keep in mind:
1. Start with a title
The first thing you should do when creating a cross reference letter is to come up with a descriptive title that accurately reflects the content of the letter. This will make it easier for the FDA to understand what the letter is about and how it relates to your application.
2. Continue with a detailed and in-depth explanation
Once you have your title, you’ll need to provide a detailed and in-depth explanation of the information contained in the letter. This should include a clear description of the relationship between your application and previous submissions, as well as any other relevant information that the FDA should be aware of.
3. Let’s explain step by step
Finally, it’s important to take a step-by-step approach when writing your cross reference letter. This will help ensure that you include all the necessary information and that the letter is as clear and concise as possible.
Examples
Example 1: Cross Reference to a Previously Filed IND
Greeting: Dear FDA Reviewer,
Body: I am writing to provide you with a cross-reference to our previously filed Investigational New Drug application (IND) for [insert drug name here]. The current application includes the same study design and endpoints as the previous IND, and we have included a summary of the results from that study in our current submission. Please let us know if you need any additional information or have any questions.
Complimentary Close: Sincerely,
Example 2: Cross Reference to a Previously Submitted Module
Greeting: Dear FDA Reviewer,
Body: I am writing to cross reference our previously submitted Module 2.5 for [insert drug name here]. The current submission includes new data on the safety and efficacy of the drug, as well as additional information on the manufacturing process. Please let us know if you need any additional information or have any questions.
Complimentary Close: Thank you for your attention to this matter.
Example 3: Cross Reference to a Previously Approved NDA
Greeting: Dear FDA Reviewer,
Body: I am writing to provide a cross-reference to the previously approved New Drug Application (NDA) for [insert drug name here]. The current submission includes updated information on the drug’s safety and efficacy, as well as new data on the manufacturing process. Please let us know if you need any additional information or have any questions.
Complimentary Close: Best regards,
Example 4: Cross Reference to a Previously Filed BLA
Greeting: Dear FDA Reviewer,
Body: I am writing to provide you with a cross-reference to our previously filed Biologics License Application (BLA) for [insert drug name here]. The current application includes updated data on the drug’s safety and efficacy, as well as new information on the manufacturing process. Please let us know if you need any additional information or have any questions.
Complimentary Close: Thank you for your attention to this matter.
Example 5: Cross Reference to a Previously Submitted Clinical Study Report
Greeting: Dear FDA Reviewer,
Body: I am writing to cross-reference our previously submitted clinical study report for [insert drug name here]. The current submission includes new data on the drug’s safety and efficacy, as well as additional information on the manufacturing process. Please let us know if you need any additional information or have any questions.
Complimentary Close: Sincerely,
Example 6: Cross Reference to a Previously Filed ANDA
Greeting: Dear FDA Reviewer,
Body: I am writing to provide a cross-reference to our previously filed Abbreviated New Drug Application (ANDA) for [insert drug name here]. The current submission includes updated information on the drug’s safety and efficacy, as well as new data on the manufacturing process. Please let us know if you need any additional information or have any questions.
Complimentary Close: Best regards,
Example 7: Cross Reference to a Previously Approved Supplement
Greeting: Dear FDA Reviewer,
Body: I am writing to provide a cross-reference to our previously approved supplement for [insert drug name here]. The current submission includes updated information on the drug’s safety and efficacy, as well as new data on the manufacturing process. Please let us know if you need any additional information or have any questions.
Complimentary Close: Thank you for your attention to this matter.
Frequently Asked Questions
What is a cross reference letter?
A cross reference letter is a document that explains the relationship between the information in a new drug application and the information contained in previous submissions.
Do I need to include a cross reference letter with my application?
Yes, if you’re submitting a new drug application, you’ll need to include a cross reference letter that explains the relationship between your application and previous submissions.
How do I create a cross reference letter?
To create a cross reference letter, you’ll need to start with a descriptive title, provide an in-depth explanation of the information contained in the letter, and take a step-by-step approach to ensure that all necessary information is included.
What information should I include in my cross reference letter?
Your cross reference letter should include a clear description of the relationship between your application and previous submissions, as well as any other relevant information that the FDA should be aware of.
Can I use examples to help me create my cross reference letter?
Yes, you can use examples like the ones provided in this article as a starting point when creating your own cross reference letter.
What should I do if I have questions about creating a cross reference letter?
If you have questions about creating a cross reference letter, you should reach out to the FDA for guidance and support.
Conclusion
Writing a cross reference letter for your new drug application can be a complex process, but with the right approach and the right examples, you can create a clear and effective letter that helps the FDA understand the relationship between your application and previous submissions. Remember to take a step-by-step approach, provide an in-depth explanation of the information contained in the letter, and use examples to guide your writing process.