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Chapter 17. Investigational Drugs

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

a. Evaluation of safety and efficacy

b. Evaluation of conflict of interest

c. Evaluation of research data

d. Evaluation of marketability

What does the IRB review research protocols for?

a. Evaluation of safety and efficacy

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

c. Risk benefit ratio

d. That the consent for is written at an appropriate reading level

What are the FDA submissions related to drug approval in the United States?

a. Orphan drug

b. Phase I, II, and III

c. IND/NDA

d. Cost recovery

Which is the most common type of IND?

a. Commercial IND

b. Treatment IND

c. Emergency use IND

d. Individual investigator IND

What are the four types of documents used to amend an IND?

a. Protocol amendments, product amendments, animal data, annual reports

b. Manufacturing changes, protocol amendments, consent form changes, annual reports

c. Protocol amendments, information amendments, IND safety reports, annual reports

d. Protocol amendments, IND safety reports, new protocols, annual reports

What would be an appropriate example of an REMS and the associated requirements to mitigate those risks?

a. Liver damage—counseling patients on signs of liver failure

b. Serious infection—sending patients home with antibiotics

c. Severe birth defects—requiring a negative pregnancy test prior to dispensing each dose of medication

d. Leukemia—meeting with an oncologist prior to initiating treatment

What is the primary reason that the FDA developed the orphan drug program?

a. To provide tax incentives to manufacturers

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