Assignment description: In completing Writing Assignment 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
Your task is to provide a HIGH-LEVEL (see template for guidance on the level of detail that is being requested) outline of the information that must be provided by your company in Modules 1 and 2 of an NDA submission, regarding its drug, CVT-301/Inbrija. This will help to align your teams on the content for these modules as you prepare to begin writing! 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). 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 Module 2. See template for details. • 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 Module 2 (such as sections 2.5 and 2.7). See template for details. • 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 Module 2 (specifically section 2.3). See template for details. • 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 Module 2 (such as sections 2.4 and 2.6). See template for details.
this Written Assignment should be comprised of 5-7 pages of content (including references).but NOT Including figures or tables, double-spaced