Utilize the following case study to evaluate and communicate your thinking on developing a compliant life-cycle management strategy:
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,
As a regulatory expert, you are charged with developing a product development plan to support an NDA submission to the US Food and Drug Administration (FDA) for each magic dust type. You are also responsible for developing a post-market approval plan to ensure ongoing maintenance of regulatory compliance after receipt of an NDA approval. Your plan should address the following “magic dust” associated questions and/or issues:
1) What pre-clinical requirements should be summarized in the clinical development plan?
2) How can the indications for use for each “magic dust” be isolated and refined? Why is it important to do this?
3) How can the risk vs. benefit profile associated with utilization of the “magic dust” for clinical purposes be established?
4) Should a randomized controlled trial design be utilized to conduct clinical research to support an NDA submission for the magic dusts or should an adaptive platform design be utilized instead?
5) Are there intellectual property issues that should be addressed?
6) How would you go about addressing pricing and reimbursement considerations?
The commercialization plan should take the form of a 14 page double spacing written document.