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When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which one of the following to FDA?

a) Adverse Event Summary Report, but only from unblinded portions of studies ("open-label IND safety report")
b) Marketing plan (i.e. annual updated projection of sales and profits)
c) IND report
d) IND renewal application

Respuesta :

Answer:

the answer is b

Explanation:

marvineetesh3

When the sponsor-investigator holds the IND for an investigational drug, he or she is responsible for reporting the Marketing plan on an annual basis.

What is a marketing plan?

A marketing plan is one of the important advertisement strategy that a company will apply to sell its goods or product. The marketing plan will support in ascertaining that the target market is the best way to reach them.

So, it can be said that When a sponsor-investigator holds the IND for an investigational drug, he or she is answerable for every year reporting the Marketing plan.

Therefore, option b is correct.

To learn more about the Marketing plan, refer to:

https://brainly.com/question/1438675

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