Utilize the following case study to evaluate and communicate your thinking on developing a regulatory submission for a new drug product in Common Technical Document format:
Imagine that you, as a regulatory science expert, go camping in a remote area of the world and find an isolated tribe of people that has not yet communicated with the rest of the world. You discover that this tribe uses several types of “magic dust” to treat a wide variety of human ailments, each with varying safety profiles and degrees of efficacy. For example, the tribe uses “magic dust #1” to treat headaches, nausea, fever and mild systemic pain, “magic dust #2” to treat cuts and bruises, and “magic dust #3” to treat insect bites. In fact, you observe that the tribe has isolated or developed at least 12 different kinds of “magic dust” and your observations suggest that the “magic dust” category as a whole seems to have a novel mechanism of action. You ask the tribe if you can have samples of each magic dust type to bring back with you for analysis and they agree. When you get home, you give these samples to the medical community, which discovers that indeed, these “magic dusts” might possibly be used effectively in the US to treat the conditions for which they are utilized by the tribe, and that their mechanism of action is, indeed, unique.
As a regulatory expert, you are charged with developing a plan to support an NDA submission to FDA for the first magic dust of your choosing. As you know, as of May 2017, all NDAs must be submitted to FDA using the Common Technical Document (CTD) format. Your plan should address the following “magic dust” associated questions and/or issues:
1) What pre-clinical requirements should be included and summarized and in what CTD Module?
2) How can the indications for use for each “magic dust” be isolated and refined? Why is it important to do this?
3) What clinical requirements should govern their approval for general use in study populations and where should this information be incorporated into the CTD?
4) How can the risk vs. benefit profile associated with utilization of the “magic dust” for clinical purposes be established and where should this be described in the CTD submission?
5) What types of quality associated documentation should be incorporated into the submission and where should this information be included in the CTD?
6) What are the components of the study including inclusion and exclusion criteria in each phase of clinical evaluation?
7) What is the general overall structure/outline of the appropriate CTD submission and what would the outline look like?
Note that you can make as many assumptions as you need to here, but these assumptions should be clearly explained and/or defined.
Important point :- Out of 12 magic dust just focus on any one throughout the paper. Since the indications for the magic dust #1, #2 and #3 is mentioned you need to choose any 1 magic dust with given indications out of 3 and just focus on that one magic dust throught the paper to answer all the 7 questions.
pages :- 12
Do include tables or pictures wherever possible.
