PharmaSchool GCP Challenge: Orphan Drugs

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Challenge: Orphan Drugs

Question Number 1:
Orphan Drug Status in the USA has a threshold value that is as follows: The disease or condition for which the drug is intended affects fewer than XXXXXXXX people in the United States or, if the drug is a vaccine, diagnostic drug, or preventive drug, the persons to whom the drug will be administered in the United States are fewer than XXXXXXXX per year. Above this threshold the Drug may still be classed as Orphan providing that certain criteria are met. What is the threshold value above?
	A	200
	B	2,000
	C	20,000
	D	200,000

Question Number 2:
Which year was the Orphan Drug Act passed in the United States?
	A	1973
	B	1983
	C	1993
	D	2003

Question Number 3:
In the USA the Orphan Drug Act is administered by the Office of Orphan Products Development. What is the European Equivalent?
	A	OOPD
	B	COPD
	C	COMP
	D	COOD

Question Number 4:
Which of the following completed the European Definition of an orphan medicinal product? "products intended to be developed for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than XXX in 10,000 persons in the European Union"
	A	1
	B	5
	C	10
	D	50