Monday, August 08, 2005

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To FDA, it doesn't matter whether the product or treatment is labeled
alternative or falls under the auspices of mainstream American medical
practice. (Mainstream American medicine essentially includes the
practices and products the majority of medical doctors in this country
follow and use.) It must meet the agency's safety and effectiveness
criteria before being allowed on the market.

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In a clinical trial, results observed in patients getting the treatment are
compared with the results in similar patients receiving a different
treatment or placebo (inactive) treatment. Preferably, neither patients
nor researchers know who is receiving the therapy under study.

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Clinical Trials
Before gaining Food and Drug Administration marketing approval,
new drugs, biologics, and medical devices must be proven safe and
effective by controlled clinical trials.

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Many advocates of unproven treatments and cures contend that
people have the right to try whatever may offer them hope, even if
others believe the remedy is worthless. This argument is especially
compelling for people with AIDS or other life-threatening diseases
with no known cure.