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pro vyhledávání: '"Cameron M. Kieffer"'
Publikováno v:
Therapeutic innovationregulatory science.
Background: Since 2008, the US Food and Drug Administration (FDA) has required that drug manufacturers conduct postmarket cardiovascular outcomes trials (CVOTs) for approved type 2 diabetes mellitus (T2DM) drugs. The utility and impact of these studi
Publikováno v:
Therapeutic innovationregulatory science. 54(3)
Background: “Patient experience data” (PED) refers to the systematic collection of meaningful data relating to the experiences, perspectives, needs, and priorities of patients. PED can augment traditional clinical trial data in the FDA’s review
Autor:
Cameron M. Kieffer, Peter W. Abel
Publikováno v:
The FASEB Journal. 32