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)
Expert Solution Preview
Introduction:
As a medical professor in charge of creating college assignments and answers for medical college students, I aim to provide comprehensive tasks that provide practical experiences and insight into the medical field. One such assignment, Writing Assignment #1 for RGA6207, requires students 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. In this answer, I will provide guidance on completing this task by answering the questions listed in the assignment.
1) Date of approval of the product:
To complete this task, students must search FDA’s available databases to identify and select an FDA approved pharmaceutical or biologic product that received final approval on or after May 1, 2017. One such product that meets this criteria is Keytruda (pembrolizumab) approved by the FDA on May 10, 2017.
2) A detailed description of the product:
Keytruda® (pembrolizumab) is a prescription medicine used to treat different types of cancer including melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) solid tumors, gastric or gastroesophageal junction adenocarcinoma, cervical cancer, and primary mediastinal large B-cell lymphoma (PMBCL).
3) Information regarding any FDA forms used in the marketing of the product:
The FDA did not require any specific forms for the marketing of Keytruda.
4) What competitor versions of the product are available:
Competing immunotherapy agents for cancer treatment include Opdivo (nivolumab), Tecentriq (atezolizumab), Imfinzi (durvalumab), and Bavencio (avelumab).
5) A brief synopsis of whether the product chosen is marketed in other global markets:
Keytruda has been approved for marketing in other global markets including the European Union (EU), Japan, and Canada.
Analysis of the risk management issues that might arise from application of FDA pre- and post-market regulations to Keytruda:
One of the most serious risks associated with using Keytruda is the possibility of immune-mediated adverse reactions, which can be severe or fatal. To manage this risk, the FDA requires Keytruda to have a Black Box Warning which is the most prominent warning on drug labeling. The FDA also requires the Risk Evaluation and Mitigation Strategy (REMS) program which is designed to inform healthcare providers of the therapy’s risks and the need for vigilant monitoring of patients during treatment. Additionally, Keytruda is subject to post-marketing studies to identify any unexpected adverse effects. Overall, the FDA’s regulations pre- and post-market for Keytruda are designed to manage the risk of serious adverse reactions associated with the drug’s use.
