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 FDAs 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 FDAs 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 products 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 FDAs 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 FDAs
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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