Chapter 21: Investigational Drugs

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 ...