From Wikipedia,
the free encyclopedia
The
United States, the
FDA approves
drugs. Before a drug can be
prescribed, it must undergo an
extensive FDA approval process.
This process involves first
testing the drug on animals or in
medical labs. If found to be safe
by the FDA and approved for the
next phase of study, the drug is
then tested for safety and
effectiveness in humans (clinical
trials). The drug manufacturer
then files a
New Drug Application to the
FDA, which reviews the application
and either approves or rejects it.
The U.S. and Canadian systems
of new drug approvals are perhaps
the most rigorous in the world. On
average, it costs a company $359
million to get one new medicine
from the laboratory to the
pharmacist's shelf, according to a
February 1993 report by the
Congressional Office of Technology
Assessment. It takes 12 years on
average for an experimental drug
to travel from lab to medicine
chest. Only five in 5,000
compounds that enter preclinical
testing make it to human testing.
One of these five tested in people
is approved.
