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Before a new medication can be prescribed or sold over the counter it
must be approved by the Food and Drug Administration or FDA. In order
for the FDA to approve a medication, the pharmaceutical company must
show that the medication is both safe and effective for use in the
treatment for which it is intended. To show this efficacy and safety
the pharmaceutical company will spend many years conducting a series of
studies. The clinical testing of experimental drugs is normally done in
three phases, each successive phase involving a larger number of
people. Once the FDA has granted a New Drug Approval (NDA),
pharmaceutical companies also conduct post marketing or late phase
three/phase four studies.
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