Which of the following was added in 1997 to the Orphan Drug Act of 1983?

A) A tax credit of 50% of the cost of conducting human clinical trials
B) Exemption from the usual drug application or user fees charged by the FDA for granted companies developing orphan products
C) Federal research grants for clinical testing of new therapies to treat and/or diagnose rare diseases
D) 7-year market exclusivity to sponsors of approved orphan products


B

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Good project management skills begin with:

a. An overview of the entire project. b. Delegation of work tasks. c. Creation of a timeline. d. Establishing quality standards.

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