Investigational new drugs are those that both sponsors and the FDA believe meet a pressing unmet medical need for a serious disease. If a drug and a particular indication receive Fast Track status, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that issues are resolved quickly, often leading to earlier drug approval and access by patients.
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Number of Investigational New Drug Applications Granted "Fast Track" Status
Count of the number of Investigational New Drug (IND) applications that were granted "fast track" status in the fiscal year.
This measure is calculated by the FDA from the CDER data systems.