When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which o

Question

3 years ago

6

When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which o

ne 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

Business

2 answers:

Anarel [89] · Answer 1 · 2022-05-03T23:25:06+03:00

Anarel [89]3 years ago

7 0

B the answer to the question

ololo11 [35] · Answer 2 · 2022-05-04T01:48:00+03:00

ololo11 [35]3 years ago

4 0

Answer:

the answer is b

Explanation: