Definition: Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling.
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Source:
ClinicalTrials.gov
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Source:
ClinicalTrials.gov
Examples: Phase III Trials are usually the last trials conducted before FDA appproval and marketing of a drug.
