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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 do drug and biologic companies provide to the FDA in exchange for the review of their applications?
- Free samples of their products
- Research data
- User fees (correct)
- Advertising services
What is the primary purpose of the Prescription Drug User Fee Act?
What is the primary purpose of the Prescription Drug User Fee Act?
- To allow the FDA to review new drug and biologic applications within certain time frames (correct)
- To punish pharmaceutical companies for unsafe drugs
- To increase the cost of prescription drugs for consumers
- To prevent the FDA from approving new drugs
What type of applications does the FDA review under the Prescription Drug User Fee Act?
What type of applications does the FDA review under the Prescription Drug User Fee Act?
- Food and cosmetic applications
- Medical device applications
- New drug and biologic applications (correct)
- Vitamin and supplement applications
What happens to the Prescription Drug User Fee Act after its initial passage?
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?
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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