Investigational drugs may also be called experimental drugs and they refer to medicines that are currently being studied in clinical trials to see if a specific disease or medical condition improves while taking it. Clinical trials help determine:
If the medicine works
If the medicine is safe
How the medicine works in that disease
How much medicine is needed
The potential benefits and risks of taking the medicine.
Investigational drugs have not yet been approved by the FDA as being safe and effective, and their labeling has not yet been approved by FDA.
