Is the FDA approving drugs too fast?
نویسندگان
چکیده
منابع مشابه
Approving new drugs.
A s the Trump administration takes shape, there is much speculation as to what major changes will be made. A dominant theme of the Trump campaign was to cut through bureaucracy in Washington, D.C., thereby enhancing innovation and bringing new technology to Americans more quickly. Nowhere could such a philosophical change have more impact than on Food and Drug Administration (FDA) approval of n...
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Implicit in the drug-approval process is a trade-off between Type I and Type II error. We propose using Bayesian decision analysis (BDA) to minimize the expected cost of drug approval, where relative costs are calibrated using U.S. Burden of Disease Study 2010 data. The results for conventional fixed-sample randomized clinical-trial designs suggest that for terminal illnesses with no existing t...
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ON AUGUST 3, 2009, THE US FOOD AND DRUG ADministration (FDA) approved pitavastatin (Livalo), making it the eighth statin approved for use in the United States and seventh currently available for sale. This approval comes almost a quarter century after that for the first member of the class, lovastatin, 8 years after generic lovastatin was approved and 4 years after 2 additional statins, pravast...
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Introduction This brief note presents an economic perspective on “me-too” drugs (sometimes also called “follow-on” drugs). Me-too drugs are products which largely duplicate the action of existing drugs. Several recent books (such as Angell (2004), Avorn (2004) and Goozner (2004)) have heaped criticism on the drug industry for the increasing extent to which investment appears to be focused on de...
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It is becoming increasingly common for user interfaces to use zooming visual effects that automatically adapt to user actions. The MacOs X ‘dock’ icon panel, for instance, uses a fisheye distortion to assist users in targeting items. Another example is ‘speed-dependent automatic zooming’, which has been shown to improve scrolling by automatically varying zoom level with scroll speed—when scroll...
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ژورنال
عنوان ژورنال: BMJ
سال: 1998
ISSN: 0959-8138,1468-5833
DOI: 10.1136/bmj.317.7163.899