Get Answer: Each Following Characteristics Question Guide

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What This Question Is About

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How to Approach This Question

Structure your response with introduction, analysis, and conclusion.

Key Explanation

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Original Question

For each of the following characteristics, indicate which designation applies. Grew out of the HIV/AIDS epidemic in the 1980s, after calls from patient advocacy groups to allow approval of drugs for life-threatening or severely debilitating diseases on the basis of a single phase II trial. “Orphan” drug Fast Track Accelerated Approval Priority Review Breakthrough Therapy This designation is based on preliminary clinical evidence of superiority over existing therapies. Sponsors can work early with the FDA to streamline the approval process through efficient design of clinical trials. In practice, this designation has been awarded to 1/3 of all new drugs, cutting the clinical development and FDA review time. “Orphan” drug Fast Track Accelerated Approval Priority Review Breakthrough Therapy The name for the pathway that cuts FDA review time to 6 months from the usual time period of 10 months. “Orphan” drug Fast Track Accelerated Approval Priority Review Breakthrough Therapy Drugs qualifying for this pathway may be approved on the basis of a surrogate measure that is only reasonably likely to predict patient benefit. “Orphan” drug Fast Track Accelerated Approval Priority Review Breakthrough Therapy

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