Sunday, November 1, 2009
Can I get a drug before it is approved by the FDA?
Until a drug receives FDA approval, it cannot be sold and the drug company may only provide it to patients through clinical trials. Furthermore, each clinical trial has specific criteria that patients must meet to be included. Occasionally, a cancer patient who is not eligible for a clinical trial may receive a promising unapproved drug, if the patient's doctor, the drug company, and FDA each agree. The FDA's primary interest is helping to ensure that the drug company's research will not subject cancer patients in the clinical trial to undue risks. The FDA drug review process guarantees that the risks and benefits of a cancer drug have been carefully considered before it is approved and helps to ensure the public that marketed drugs are safe and effective.
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