Similar or Alternative Terms Meaning the Same Thing
New Molecular Entity (NME)
New Drug Application (NDA)
The process of getting a drug approved by the FDA -- the investigational new drug
("IND") process -- is costly and time-consuming. The IND process typically has three separate
"Phase I" trials, evaluate the safety of the medication by studying the effect of the drug
and are designed to determine the metabolic and pharmacologic actions of the drug in humans,
the side effects associated with increasing doses, and, if possible, to gain early evidence on
"Phase II" trials are designed to obtain preliminary data on the effectiveness of the
drug for a particular indication or indications in patients with the disease or condition.
"Phase III" trials, are intended to gather additional information about effectiveness and safety that is
needed to evaluate the overall benefit-risk relationship of the drug.
Many drugs, like
chemotherapy for an example, have deeply deleterious -- sometimes even fatal -- side effects, and
part of the FDA approval process is weighing the potentiality for those side effects against the
disease process the drug is designed to treat. The sponsor's goal at the end of the IND process is
an approved New Drug Application ("NDA").