CNPR Healthcare Industry Knowledge & Drug Approval Process

Question 1

What is the first phase of clinical drug trials?

Accepted Answer

Phase I

Answer

Phase IV

Answer

Phase III

Answer

Preclinical Testing

Question 2

Which U.S. agency is responsible for approving new drugs?

Accepted Answer

FDA

Answer

CDC

Answer

DEA

Answer

NIH

Question 3

What is the purpose of Phase III clinical trials?

Accepted Answer

To compare with existing treatments and ensure effectiveness

Answer

To study drug manufacturing processes

Answer

To assess long-term safety only

Answer

To gain approval for animal use

Question 4

What document is submitted to the FDA to begin clinical trials?

Accepted Answer

IND

Answer

NDA

Answer

ANDA

Answer

BLA

Question 5

Which phase focuses on long-term safety and effectiveness after approval?

Accepted Answer

Phase IV

Answer

Phase II

Answer

Phase I

Answer

Preclinical

Question 6

What is the NDA in the drug approval process?

Accepted Answer

New Drug Application

Answer

New Development Application

Answer

National Drug Authority

Answer

National Drug Approval

Question 7

Why is preclinical testing conducted before human trials?

Accepted Answer

To assess safety before human exposure

Answer

To determine profitability

Answer

To ensure no clinical trials are needed

Answer

To predict the drug’s market success

Question 8

Who oversees the drug approval process in the EU?

Accepted Answer

EMA

Answer

FDA

Answer

CDC

Answer

WHO

Question 9

What is the role of the Institutional Review Board (IRB)?

Accepted Answer

To ensure ethical conduct in human research

Answer

To fund drug development

Answer

To conduct the trials

Answer

To monitor drug distribution