Risks in new drug development: approval success rates for investigational drugs.
نویسنده
چکیده
منابع مشابه
Economics of new oncology drug development.
PURPOSE Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. METHODS We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estim...
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The Food and Drug Administration (FDA) reviews clinical-trial data for new drugs and determines whether the benefits of these drugs outweigh the risks.1 This requirement, legislated in 1962,2 raised the bar to approval and reduced the likelihood that new drugs would be ineffective or cause major health problems. Developing such data about investigational drugs takes time for the assessment of p...
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On December 14, 2006, the Food and Drug Administration (FDA) proposed two new regulations in the Federal Register amending current regulations governing expanded access to investigational drugs for treatment use and charging for investigational drugs. The proposals come at a time when FDA has found itself under new pressure to provide seriously ill patients with early access to investigational ...
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The effects of incorporating a biomarker-based (personalized or precision) selection strategy on drug development timelines for new oncology drugs merit investigation. Here we accessed documents from the Food and Drug Administration (FDA) database for anticancer agents approved between 09/1998 and 07/2014 to compare drugs developed with and without a personalized strategy. Sixty-three drugs wer...
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Victims of AIDS and other incurable diseases are denied access to potentially valuable experimental drugs by the U.S. Food and Drug Administration. Under the present law, no new drug or medical device can be sold until it has been approved as safe and effective" by the FDA. New-drug approval is an expensive process that routinely takes years to complete. Unapproved experimental products cannot ...
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عنوان ژورنال:
- Clinical pharmacology and therapeutics
دوره 69 5 شماره
صفحات -
تاریخ انتشار 2001