What is an investigational drug?
A drug is considered to be investigational if it is being tested in people, but has not yet been approved for marketing by the US Food and Drug Administration (FDA) by proving to be both safe and effective for the diagnosis, prevention, or treatment of a defined disease or condition. A drug may be approved by the FDA for use in one disease or condition, but be considered investigational in other uses. What is the difference between “standard therapy” and “experimental therapy” in clinical trial? In medicine, standard therapy is the treatment that experts agree is appropriate, accepted, and widely used. Healthcare providers are obligated to provide patients with standard therapy. Standard therapy is also called standard of care or best practice. In clinical trials, experimental therapy refers to a drug (including a new drug, new dose, combination with other drugs, or route of administration) or procedure that has undergone basic laboratory testing and received approval from the FDA to b
A drug is considered to be investigational if it is being tested in people, but has not yet been approved for marketing by the US Food and Drug Administration (FDA) by proving to be both safe and effective for the diagnosis, prevention, or treatment of a defined disease or condition. A drug may be approved by the FDA for use in one disease or condition, but be considered investigational in other uses.
