Approval of new drugs in oncology – a changing pattern
نویسندگان
چکیده
Patients with advanced malignancies have high-unmet medical needs, which bring requests for early availability of new innovative treatments. Calls expedited trial formats and rapid regulatory a...
منابع مشابه
Reevaluating the accelerated approval process for oncology drugs.
For a new therapy to qualify for the accelerated approval pathway, it must treat a serious disease for which there is "unmet medical need"--defined as providing a therapy where none exists or providing a therapy that may be potentially superior to existing therapy. The increasing number of available therapies, coupled with the lack of accepted endpoints considered "reasonably likely to predict ...
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15 صفحه اولEnd points and United States Food and Drug Administration approval of oncology drugs.
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ژورنال
عنوان ژورنال: Acta Oncologica
سال: 2021
ISSN: ['1651-226X', '0284-186X']
DOI: https://doi.org/10.1080/0284186x.2021.1877345