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CVT 301 NU Impact of Electronic Common Technical Document Submissions Letter

Description

Part 2, form 356h: You will go to the forms webpage provided by FDA and download form 356h, the form that is submitted with Module 1 (see here: https://www.fda.gov/about-fda/reports-manuals-forms/forms (Links to an external site.)

Assignment description:

In completing Writing Assignment #2 for RGA6207 students will have the opportunity to:
Demonstrate an understanding of the components of Modules 1 and 2 of the eCTD

Demonstrate an ability to interpret a publicly available FDA Summary Review file to understand what information was submitted by the sponsor for the NDA
Demonstrate an ability to adequately access relevant, current FDA guidances/forms with respect to completion of Modules 1 and 2
For this assignment, you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology company that has completed all aspects of development for a combination drug/device product called CVT-301. CVT-301 was developed for treatment of the symptoms of Parkinson’s Disease and your company is now ready to begin preparation for submitting its NDA for CVT-301, also known as Inbrija.
Part 1 Details:
This assignment is focused on “reverse engineering” an FDA drug approval package to fit the outline of an NDA submission in the eCTD format.  Your task is to provide examples of the types of information that must be provided by your company in Modules 1 though 5 of an NDA submission.  For this assignment you should use the approved drug “Inbrija“.  Inbrija’s pre-approval name was CVT-301, so you will see this name also referenced in the drug approval package.

For this task, you will use publicly available information from the FDA Approved Drugs Database (see here: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm (Links to an external site.)). You should conduct a search for “Inbrija” and locate the “Approval Date and History, Letters, Labels, Reviews for NDA” tab.
You will use the following documents under “Application Review Files:”
Summary Review: This file provides a high-level summary of the FDA’s entire review of the NDA for Inbrija. You can use information from this form to complete your high-level review of Module 1 and parts of Modules 2-5.

Medical Reviews: This is a summary of all the clinical information from the NDA application, as reviewed by FDA. You can use parts of this to complete the high-level summary for clinical aspects of Modules 2 and 5.
Chemistry Reviews: This is a summary of all the quality (CMC) information from the NDA application, as reviewed by FDA. You can use parts of this to complete the high-level summary for quality aspects of Modules 2 and 3.
Pharmacology Review: This is a summary of all the nonclinical information from the NDA application, as reviewed by FDA. You can use parts of this to complete the high-level summary for nonclinical aspects of Modules 2 and 4.
You should use and follow the directions in the assignment #2 template so that you can be sure only to include relevant information and not get sucked down a hole of providing too much detail for this assignment!
Part 2 Details:
As the Sr Manager of Regulatory Affairs, it is your task is to take a first pass at completing the form 356h (the FDA’s form for submission of a New Drug Application that is included in Module 1). The form 356h can be found here: https://www.fda.gov/about-fda/reports-manuals-forms/forms (Links to an external site.). You can use information from the “Summary Review” document outline above, to help you complete form 356h.

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