When reviewing information about the Orphan Drug Program, which of the following would the nurse expect to find? Select all that apply
A) The program encourages the development and marketing of products to treat rare diseases.
B) The program grants provisional approval with a written commitment from the drug company to formally demonstrate client benefits.
C) The program provides for incentives, such as research grants, protocol assistance, and special tax credits, to develop products to treat rare diseases.
D) The program grants 7 years of exclusive marketing rights to the manufacturer if approved.
E) The program accelerates approval of drugs based on preliminary evidence before formal demonstration of client benefits.
Ans: A, C, D
Feedback:
The Orphan Drug Program encourages the development and marketing of products used to treat rare diseases. The program provides incentives to encourage manufacturers to develop orphan drugs, and if approved, the manufacturer has 7 years of exclusive marketing rights. Accelerated programs involve provisional approval and approval based on preliminary evidence.
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