Skip to Main Content

++

Chapter 21: Investigational Drugs

++
++
++

What is the primary role of the FDA related to drugs, biologics, and medical devices in the United States?

++
++
++

a. Evaluating the safety and efficacy of the products

++
++

b. Determining that the rights and welfare and human subjects are protected

++
++

c. Evaluating of prescribing trends of physicians among similar products

++
++

d. Determining the price of the products

+
++

a. Evaluating the safety and efficacy of the products

++
++
++

What is the primary purpose of IRB review of research?

++
++
++

a. Evaluating the safety and efficacy of products used in an investigational protocol

++
++

b. Determining that the rights and welfare and human subjects are protected

++
++

c. Evaluating the risk benefit ratio of an investigational protocol

++
++

d. Determining that the consent form is written at an appropriate reading level

+
++

b. Determining that the rights and welfare and human subjects are protected

++
++
++

The drug approval process in the United States as codified by the FDA includes:

++
++
++

a. Phase I to V testing

++
++

b. Postmarketing usage evaluations

++
++

c. IND/NDA (BLA) submissions

++
++

d. Cost recovery evaluations

+
++

c. IND/NDA (BLA) submissions

++
++
++

A treatment IND:

++
++
++

a. Is any IND that includes a product with therapeutic intent

++
++

b. Allows for treatment of patients even when consent cannot be obtained

++
++

c. Is part of Fast Track review

++
++

d. Allows for increase accessibility of the product for widespread use

+
++

d. Allows for increase accessibility of the product for widespread use

++
++
++

IND safety reports:

++
++
++

a. Are submitted annually to describe the progress of the investigation

++
++

b. Should be submitted if a manufacturing change may impact product safety

++
++

c. When there is proof that an adverse event is related to the product

++
++

d. Should be submitted for new safety data obtained from humans or animals

+
++

d. Should be submitted for new safety ...

Pop-up div Successfully Displayed

This div only appears when the trigger link is hovered over. Otherwise it is hidden from view.