Impact of FDA guidance for developing diabetes drugs on trial design: from policy to practice.
In 2008, the US Food and Drug Administration (FDA) issued guidance requiring robust assessment of cardiovascular safety for all antidiabetic drugs to be licensed in the future. Here, we review the circumstances giving rise to the FDA guidance and describe the characteristics of clinical trials regis...
Үндсэн зохиолчид: | , |
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Формат: | Journal article |
Хэл сонгох: | English |
Хэвлэсэн: |
2012
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