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Questions and Answers
What do drug and biologic companies provide to the FDA in exchange for the review of their applications?
What is the primary purpose of the Prescription Drug User Fee Act?
What type of applications does the FDA review under the Prescription Drug User Fee Act?
What happens to the Prescription Drug User Fee Act after its initial passage?
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When was the Prescription Drug User Fee Act first passed?
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Study Notes
Prescription Drug User Fee Act
- Enacted in 1992 and has been renewed subsequently
- Enables the FDA to accept user fees from drug and biologic companies
- In exchange, the FDA commits to review new drug and biologic applications within specific time frames
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Description
This quiz covers the Prescription Drug User Fee Act, which allows the FDA to collect user fees from drug and biologic companies in exchange for faster review times.
