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>新着情報 >2How to use the FDA website to find drug dataThe European
2How to use the FDA website to find drug dataThe European

By comparing drug regulatory data with the published literature pandora charms, researchers can uncover reporting bias, and researchers have been advised to use such data in systematic reviews1 and meta analyses.2How to use the FDA website to find drug dataThe European Medicines Agency has been making clinical trial data available on request since November 2010,3 and next year, notwithstanding legal challenges, it will expand access by making data publicly available for download from its website.4 5 Unlike, the EMA, the US Food and Drug Administration does not make individual patient data available. However, drug approval packages, also referred to as reviews or summary basis of approval documents, have been available on the FDA website since 1997.6 7 These are filtered summaries of clinical study reports and related documents, written by FDA staff, who may review “pivotal trials” in more depth than other trials.Although regulatory data have been used in several studies,8 9 10 11 12 13 they are underused. An obstacle to the use of FDA drug approval packages may be that it is difficult to navigate to and within these documents.Various publications have advocated the use of FDA data,1 7 15 16 17 18 19 20 but few have provided instructions for doing so.17 21 Below https://www.pandorasalesbracelet.com/, I provide a detailed, annotated procedure for accessing drug approval packages and suggest how to make them more easily usable.

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