Medical Letter on the CDC & FDA
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SAGE Publications
FDA ignores critical information on home HIV tests
June 21st, 2009
Los Angeles, London, New Delhi, Singapore and Washington DC (May 29, 2009) The FDA is ignoring critical information in deciding whether to approve an over-the-counter, rapid HIV test for home use, according to a recent article in the journal Medical Decision Making (MDM) which is published by SAGE. As the price of the HIV test rises, some lower-income individuals who are at greater risk for HIV infection will not be able to afford it. The FDA has been criticized because it bases its decisions on small studies performed in non-representative populations. "When approving new technologies, the FDA should focus less on the general population and more on...
Source: Medical Letter on the CDC & FDA (2009-06-21)
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