New York University New Drug Application CVT 301 Paper

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Business Finance

New York University

Description

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

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Explanation & Answer

Attached.

Running Head: NDA-CVT-301

1

New Drug Application: CVT-301
Name
Institution

NDA-CVT-301

2
1.2 The Cover Letter

The NDA is the application that a drug manufacturer submits to the FDA for marketing
approval. This helps the FDA gather information about the efficacy, the safety of the drug, as
well as establish whether the benefits exceed the risks (FDA, 2019). The information regarding
the contents of the cover letter has been derived from the NDA, ANDA submissions Guidance
document by the FDA. Hyperlink https://www.fda.gov/media/123269/download
Information submitted in the cover letter could include:


The drug substance name, which is Inbrija (Levodopa) in our case; the strength, which is
42mg; administration mode (oral inhalation), and the name of the applicant.
• In the product overview, the applicant should include the targeted indication for the drug and
also patient population (in our case, Inbrija is indicated for the treatment of symptoms in
patients with Parkinson’s Disease.). It should also include the dosage, which is 84 mg, with a
maximum daily dose of 420 mg. Other information could consist of the duration of treatment,
and also the alternative mode of administration (where applicable) (FDA, 2018).
• The cover letter should also summarize information regarding the size of the tablet (physical
description), the active ingredients, and the formulation of the dosage. Also, a description of
packaging for single patient use should be given and tamper resistance information.
• Also, a summarized description of the clinical and nonclinical overviews should be included
to help the FDA establish the pharmacological, pharmacokinetics, and toxicological
information regarding the drug (FDA, 2018).
• Other essential information includes a description of the sites where the batches will be
manufactured, the proposed expiration date, and safety information for the drug. This could
include a summarized evaluation of possible risks and ways to mitigate the risks.
• The name and contact information of the applicant and or the technical point of contact should
be provided.
2.2 Introduction
Before a drug manufacturer is allowed to market new drugs in the U.S, it is required to
provide necessary information to the FDA to show that the product is effective and safe. This
also aims to ensure that the manufacturer follows all the proposed and recommended guidelines
for the development and labeling of the product.
In the introduction, it is crucial to describe the documentation information that is required
during NDA submissions to ensure the reader is aware of what module 2 comprises of. A lack of
a standardized guideline could result in the omission of essential information resulting in refuse
to file an application (RTF) feedback by the FDA. In the guideline for submitting marketing
applications, which the source for this introduction, we are given considerations that should be
made while developing submission documents, including the use of ICH-CTD format. These are
common formats that are used in the U.S, E.U, and Japan.
Also, the introduction should include a summary of the formatting of the new drug
application, which is as a result of the harmonization among the three regions. For instance, the
marketing application has five modules from module one to five. Module one consists of all the
administrative documents, such as the forms for application, cover letters, and labeling
information. Also, a summary of module two should be given. This includes information on

NDA-CVT-301

3

documents, including the quality overall summary document, nonclinical and clinical overview
documents, non-clinical summary, and clinical summary documents. Other modules like module
three include quality information, module four contains the study reports for nonclinical studies,
and module five should include reports on clinical studies regarding the drug.
The Source ...


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