Subject: General Questions    / General General Questions
Question

Upon reading Chapter 4 of your main textbook on “Regulatory Compliance”, please POST your answers on the Discussion board for the following 6 questions. This is assuming that you are an executive of the leadership team at StemTechnolUS, to develop and implement a regulatory strategy and compliance protocols for the stem cell technology product for your company.

“Your firm, StemTechnolUS, develops human therapeutic products from human pluripotent stem cells. You have discovered and cloned a stem cell derived cell line that differentiates into neurons and is suitable for repair of uncomplicated spinal cord injuries from blunt trauma. Cells can be given by surgical intervention. Your company and its investors plan to develop the technology into major viable products for the medical community. However, you will need to develop a regulatory strategy and compliance scheme and assure that the product development will meet the required GMP process, for both clinical trial testings and subsequent commercial uses.”

Questions:

1- What is the nature and timing of meetings or teleconferences that might be held with the FDA during the development process and before receiving market approval, assuming positive clinical trial results?

2- As designed, could your product be considered in any way a combination product? Explain the rationale for this conclusion. If it is a combination product, then describe the impact on the regulatory plan and development pathway.

3- Describe the major risks and benefits for the product, as FDA might perceive. Discuss the factors that will enter into a regulatory review of the risk-to-benefit ratio for this product.

4- Describe post-marketing activities that might be required by regulatory agencies for this type of product or indication?

5- What non-FDA regulatory hurdles must be considered for this type of product? Do these hurdles pose major obstacles to product development, and if so, how will they be addressed and resolved?

6- How might you add value or speed the development of this product by using various opportunities provided by FDA? Describe these programs the guidelines.

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