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Chapter 17. Investigational Drugs

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

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a. Evaluation of safety and efficacy

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b. Evaluation of conflict of interest

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c. Evaluation of research data

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d. Evaluation of marketability

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What does the IRB review research protocols for?

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a. Evaluation of safety and efficacy

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

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c. Risk benefit ratio

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

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

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a. Orphan drug

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b. Phase I, II, and III

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c. IND/NDA

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d. Cost recovery

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Which is the most common type of IND?

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a. Commercial IND

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b. Treatment IND

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c. Emergency use IND

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d. Individual investigator IND

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

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

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

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

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

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

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

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b. Serious infection—sending patients home with antibiotics

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

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

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

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a. To provide tax incentives to manufacturers

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