Topic: Hereditary Angioedema (HAE) or Oral Iron Chelators as an indication for treatment of Thalassemia or another type of Anemia
Order Description
Here is your first written assignment and it is your mid-term paper. Please note that this paper is due to me by midnight EST on March 3.
As a regulatory professional it is key that you fully understand the disease condition/indication your drug/biologic is being developed for. You must understand this in order to develop regulatory strategy and provide regulatory guidance to the rest of the development team. Your first written assignment is to research and describe one of the indications for drug development: Hereditary Angioedema (HAE) or Talassemia minor (Iron chelation therapy). Do this from the perspective of a regulatory professional who is new to the indication and is developing the background necessary to support a team developing a new drug to treat HAE. Please provide a detailed overview of the disease that includes: the natural history of disease, the incidence and prevalence of HAE in the U.S., how HAE is diagnosed and treated, what are the approved treatments (if any), are there unapproved treatments, etc. Please keep this to no more than 10 pages.
Please do not forget to reference your sources of data. Make sure you footnote appropriately!
Let me know if you have any questions.
^this is from the blackboard. i will attached the information that help you to do the research please do your best because itÂ’s 25% from the course.
Thank you.
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