Zobrazeno 1 - 6
of 6
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
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f02f778fa13e7d56364f9ce1bd722f62
https://pubmed.ncbi.nlm.nih.gov/31311308
https://pubmed.ncbi.nlm.nih.gov/31311308
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
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d5431bc1a5161d0ff9d08454ca6bb49d
https://pubmed.ncbi.nlm.nih.gov/33301134
https://pubmed.ncbi.nlm.nih.gov/33301134
Autor:
Cameron M. Kieffer, Peter W. Abel
Publikováno v:
The FASEB Journal. 32
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::52fcf8e71ac5f3af21e2cdfae60db129
https://doi.org/10.1096/fasebj.2018.32.1_supplement.834.1
https://doi.org/10.1096/fasebj.2018.32.1_supplement.834.1
Publikováno v:
Therapeutic Innovation & Regulatory Science; Jun2020, Vol. 54 Issue 3, p640-644, 5p
Publikováno v:
Therapeutic Innovation & Regulatory Science; Jun2020, Vol. 54 Issue 3, p709-716, 8p
Supplemental Material, Supplementary_Table_1 for FDA Reported Use of Patient Experience Data in 2018 Drug Approvals by Cameron M. Kieffer, Alexis Reisin Miller, Benjamin Chacko and Andrew S. Robertson in Therapeutic Innovation & Regulatory Science
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::492a0832f65d28b4194349476245c74a
