Question: Question 2 (20 marks) Approval from FDA is required before a drug company can market their drug on the market. Your company is working on

Question 2 (20 marks)

Approval from FDA is required before a drug company can market their drug on the market. Your company is working on a drug against Covid-19 outbreak.

(a) Suggest and justify the most suitable approval status that your company can seek when submitting your application for FDA approval. (4 marks)

(b) Suggest FOUR (4) options available with justification, if your company fail to obtain approval. (12 marks)

(c) An approved indication is allowed on labeling a drug. However, off-label uses may be initiated by the drug manufactures or physicians. Examine FOUR (4) concerns associated to the off label uses of a drugs. (4 marks)

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