FDA

bjjones

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A question, I am not from US and I don't know how it operates FDA. Are the phases 1,2 and 3 of clinical trials accomplished during the submission of the protocol to FDA or the results of the clinical trials are submitted later to FDA ?
 

2young

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I believe the clinical trials are conducted prior to approval. Upon sucessful completion of clinical trials, the durg company applies for FDA approval, the FDA reviews the results of the trials, and then approval is granted or denied.
 
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