RGA 6207 Reverse Translation Baxdela Writing Project

In completing Writing Assignment #1 for RGA6207 students will have the

opportunity to “reverse translate” an FDA approved product insert and other

documentation associated with approval of a pharmaceutical or biologic product

back to the information submitted by the manufacturer in Module 1 of an eCTD

submission. As discussed during Week 3 of the course, the required content for the

US version of Module 1 is described by v2.3.2 of FDA’s Comprehensive Table of

Content Headings (11/1/2018). This document was included in your Blackboard

Reading Materials folder in Week 3. Specific instructions are as follows:

• Search FDA’s available database(s) to identify and select an FDA approved

pharmaceutical or biologic product that received final approval on or after

May 1, 2017.

• Locate the approved product insert, as well as any other regulatory

documentation associated with the product’s conditional marketing approval

• Provide a description of the information that would likely have been

submitted in the following sections of CTD Module 1, per the instructions

outlined in v2.3.2 of FDA’s Comprehensive Table of Content Headings

(11/11/2018):

– 1.14 Labeling

– 1.15 Promotional Material

– 1.16 Risk Management Plan

– 1.17 Post-Marketing Studies

– 1.18 Proprietary Names

Your description should summarize the information that you are able to

obtain on your conditionally approved product from the FDA website, as well

as from general Internet-based sources. Internet based sources can be

particularly useful to identify promotional materials utilized by product

manufacturers to market the pharmaceutical or biologic product. The FDA’s

Office of Prescription Drug Promotion (OPDP) can often be helpful in this

regard.

• From a holistic perspective, please provide an analysis of the risk

management issues that might arise from application of FDA pre- and post-

market regulations to your product selection. Please include this as part of

your description of M1 section 1.16.

Also, please ensure that your submission includes the following information for your

chosen product

1) Date of approval of the product

2) A detailed description of the product

3) Information regarding any FDA forms used in the marketing of the product

4) What competitor versions of the product are available

5) A brief synopsis of whether the product chosen is marketed in other global

markets (i.e any of the EU5 – Germany, the UK, Italy, France, Spain, Japan,

Canada)

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