The FDA will be quick to point out they do not 'approve' drugs or medical devices, the 'clear' them. Mr. Schorr is quite correct, though, there is no need for a drug or device to be an improvement on time tested items already on the market; they must only submit data proving equivalency in effectiveness and safety. Although testing --often requiring years--is done there is no way to expose the drug or device to the number of applications it will see in the real world; therefore, the lower probability risks will escape notice until after market release. A conservative physician will steer patients to the standard-of-care treatment and await further reports.
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The FDA will be quick to point out they do not 'approve' drugs or medical devices, the 'clear' them. Mr. Schorr is quite correct, though, there is no need for a drug or device to be an improvement on time tested items already on the market; they must only submit data proving equivalency in effectiveness and safety. Although testing --often requiring years--is done there is no way to expose the drug or device to the number of applications it will see in the real world; therefore, the lower probability risks will escape notice until after market release. A conservative physician will steer patients to the standard-of-care treatment and await further reports.
June 27, 2011 - 7:58amThis Comment
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