The written assignments will follow a particular disease state and product, of the student’s choosing, over the course of its development from pre-clinical to clinical, and post-market. The assignments will build upon one another and will involve writing summaries of critical components of clinical trial or marketing applications for the chosen product.
These assignments will give students an opportunity to increase their familiarity with the writing styles as well as processes associated with seeking FDA regulatory approval to market drug products, as well as have the student demonstrate how that product entered the market using regulatory strategy.
Time spent up front researching a product that has the most available information within the public domain will save you anguish later as the expectation in assignment completion become more detailed and precise.
Follow the instructions below.
Choose a disease state and drug product which interests you using drugs@fda.gov.
Investigate the chosen disease state with regard to:
Prevalence in the United States.
Presence of patient advocacy groups.
Conferences where this disease state is typically discussed.
Copy and paste the below content (bolded for ease of use) into a Word document, and respond to each question. You may alter the question as indicated by filling in the information noted in the brackets (< >), or where a choice in wording is noted (i.e., is/are, etc.).
There is no requirement regarding word count or number of pages. However, the more detailed and precise you are in your writing, the more successful you will be.
RGA 6310
<Your Name Here>
The disease state and drug product I have chosen to follow throughout the semester is:
The mechanism of physiology of the disease state is/is postulated to be:
The prevalence of the disease state within the United States is:
The prevalence of the disease state globally is:
The patient population is typically categorized by the following clinical symptoms:
The patient advocacy group(s) which exist for <DISEASE STATE> is/are:
6.1 The mission of the patient advocacy group(s) is/are:
6.2 If no patient advocacy groups exist, postulate why.
The conference(s) and congress(es) where <DISEASE STATE> is typically reviewed and discussed is/are:
7.1 In the most recent conference <NAME of CONFERENCE>, the following therapies were discussed and presented (list 3):
7.2 Key speakers at the <NAME of CONFERENCE> included (list 3):
The therapy [i.e., product] I will be researching in relation to my chosen disease state is:
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