++
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:
++
++
++
++
++
b. Postmarketing usage evaluations
++
++
c. IND/NDA (BLA) submissions
++
++
d. Cost recovery evaluations
+
++
c. IND/NDA (BLA) submissions
++
++
++
++
++
++
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
++
++
++
++
++
++
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 ...