§314.53 Submission of patent information

The items that need to be disclosed are:

1. New drug application number
2. Name of new drug application sponsor
3. Trade name
4. Active ingredient(s)
5. The strength of the new drug
6. The dosage form
7. The patent number
8. The patent owner's full name, phone number, address, e-mail address, and fax number (if available).
9. Information on any previous submissions
10. Information on the expiration date
11. Information on whether the patent is a product-by-process patent
12. Information on the drug substance
13. Information on the drug product
14. Information on each method-of-use
15. The approved drug product or methods of use
16. A signature verifying that the submitted information if accurate
17. Signatures of all other authorized personnel and full name, address, phone number, e-mail, and fax number (if available)

This relates to the CTD format because §314.53 informs the applicant on what is needed to submit an NDA and the CTD format provides support for an NDA submission.

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§314.3 Definitions

I believe the most important terms an applicant needs to understand prior to submission are: Complete response letter, Class 1 resubmission, Class 2 resubmission, and Resubmission.

The Complete response letter allows the applicant to fully understand what needs to occur prior to approval.

Although Class 1 resubmission and Class 2 resubmission are both application resubmissions, the applicant should understand why the FDA is requesting a resubmission.

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Module 1 contains administrative information and prescribing information Module 2 contains an overview and summary of modules 3 - 5 Module 3 contains ICH M4Q(R1) - This code is for Quality Module 4 contains ICH M4S(R2) - This code is for Safety (non-clinical study reports) Module 5 contains ICH M4E(R1) - This code is for Efficacy (clinical study reports)

https://via.hypothes.is/http:/www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/CTD_triangle.pdf

(a) Application Form

The required form the FDA wants completed and signed is the New Drug Application (NDA). The application can be a resubmission, an amendment, or a supplement.

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applicant

The applicant is anyone who submits an application to the FDA to gain approval of a new drug.

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