Facts on File Encyclopedia of Health and Medicine

restricted approval for use in clinical testing, emer-
gency 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 clini-
  cal 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 unap-

proved drugs (www.fda.gov).

See also ANTIBIOTIC RESISTANCE; OFF-LABEL USE;

ORPHAN DRUG.

160 Drugs