Clinical Trial Phases
IND Exempt Clinical Trials
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“IND Exempt Clinical Trials” are a slight variation on approved drugs. For example, the trial tests a change in scheduling or dosage. These trials are not really Phase IV, but are similar.
IND Exempt Clinical Trials are usually initiated by an investigator, not a pharmaceutical company.
The FDA doesn’t review these trials. It sets the criteria for IND Exempt Clinical Trials in regulations. If a trial wants to go outside the regulations, it requires FDA review.
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