regulatory affairs

regulatory affairs

Paper details:

Question 1:
Combination products are complex and probably require more development time and associated costs. Your biotechnology company Awesome plans to partner up with a medical device company Cool to develop a biologic-medical device combination product to treat a cardiovascular disease. The CEO of Awesome asks that you as VP of clinical and regulatory affairs present to the executive committee your proposed regulatory strategy to obtain approval for this combination product. Keep in mind that you will be working with a partner on this combination product.

1) What clinical regulatory strategies should you present to the executive committee to help them make an informed business decision (e.g., whether to proceed with this combination product with Cool) ?
2) What due diligence should be done prior to your presentation to the executive committee ?
3) How should you approach the Office of Combination Products, if at all ? If you do decide to contact the Office of Combination Products, when and what questions should be asked ?

Question 2:
Combination products are increasingly becoming popular with industry and certainly pose new challenges for FDA to review and regulate. In the era of personalized medicine, a diagnostic test usually accompanies a drug or a biological product.

Discuss (1) at least 3 points why you think combination products are gaining popularity and (2) the potential issues/questions (in the near future) that FDA may have to address and your proposed solutions.
Question 3:
Under which circumstances is a CBER inspection likely to take place?
Question 4:
Under what circumstances will CBER want to inspect an IRB?
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