BTEC 3317 Final Exam (A+ Guaranteed)

Based on FDA's definition of a drug, what is a drug not supposed to do to a patient's disease or condition? Treat Prevent Exacerbate Diagnose Mitigate correct answers Exacerbate What is not a good reason as to why there may remain a market for a new drug even if there is already an approved drug for a particular indication? The new drug for headache is a combination tablet that contains two different APIs while currently, two tablets have to be taken separately to get headache relief The currently marketed drug is very expensive The currently marketed drug is injectable while the new drug will be oral An anti-depression drug that produces suicidal thoughts will be preferred over an already marketed one that doesn't For any given drug, more than 50% of patients with a condition may not respond to the existing drug correct answers An anti-depression drug that produces suicidal thoughts will be preferred over an already marketed one that doesn't FDA defines a drug as any substance used for diagnosis, control, mitigation, prevention or treatment of disease. What would be an example of a combination drug product? Pregnancy test kit Dental floss Tongue depressor Baby aspirin Lab microwave correct answers Pregnancy test kit Orphan drugs are pharmaceutical and biological products that target diseases affecting under 200,000 patients in the US. What is not an incentive given to manufacturers to encourage the development of orphan drugs? Clinical trial requirement is waived PDUFA fees are waived Smaller patient numbers are required for clinical trials No other version of the drug will be approved during a seven year market exclusivity Tax incentives are given to the manufacturer correct answers Clinical trial requirement is waived What is not true of biosimilars?