Before Trials
To legally test the drug on human subjects in the U.S., the maker must first obtain an Investigational New Drug (IND) designation from FDA. This application is based on pre-clinical data, typically from animal studies after P1, that shows the drug is safe enough to be tested in humans.
Often the "new" drugs that are submitted for approval include new molecular entities or old medications that have been chemically modified to elicit differential pharmacological effects or reduced side-effects.
Read more about this topic: New Drug Application
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