Encyclopedia of Health and Medicine

160 Drugs
restricted approval for use in clinical testing, emergency
treatment, or transportation across state
lines. Typically the use of an IND must meet one
of three requirements:
• The person to receive the IND enrolls in a clinical
research study that is evaluating the drug’s
effectiveness, benefits, and risks among the
drug’s intended patient population.
• The person to receive the IND has a serious or
life-threatening condition the IND is being
developed to treat, and there are no ongoing
clinical research studies in which the person
can enroll.
• The person to receive the IND has a serious or
life-threatening condition the IND is being
developed to treat, and the FDA is in the
process of reviewing the drug’s clinical research
data.
The most commonly used INDs are antibiotics
used to treat multiple-drug-resistant infections
and drugs to treat cancer. On its Web site the FDA
maintains lists of current INDs by type of drug and
information about how to gain access to unapproved
drugs (www.fda.gov).
See also ANTIBIOTIC RESISTANCE; OFF-LABEL USE;
ORPHAN DRUG.