Zobrazeno 1 - 10
of 21
pro vyhledávání: '"Rachel E. Sherman"'
Publikováno v:
Nature reviews. Drug discovery. 19(12)
Randomized controlled trials are the accepted standard for evaluating investigational therapies, but such trials are sometimes not an option for reasons of ethics or feasibility. Here, we discuss opportunities to address evidence gaps by using histor
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c113e610e3db3510ab1d1764fb602abc
https://pubmed.ncbi.nlm.nih.gov/32811986
https://pubmed.ncbi.nlm.nih.gov/32811986
Autor:
Nina L. Hunter, Rachel E. Sherman, Michael J. Rappel, Kyle O. Hair, Robert M. Califf, April I. Alexandrow
Publikováno v:
Clinical and Translational Science. 10:124-127
Therapeutics known as combination products because they combine drug, device, and/or biologic elements can offer important advantages relative to single‐modality products. However, regulatory policy in this arena has lagged relative to increases in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::07f541884218f9a2cdf5c2006a01e69c
https://doi.org/10.1111/cts.12441
https://doi.org/10.1111/cts.12441
Publikováno v:
Nature reviews. Drug discovery. 16(11)
Scientific advances, in combination with government incentives and commercial opportunity, have fuelled strong investment in orphan drugs, resulting in many innovative therapies. Here, we discuss the approach of the FDA to a range of issues that rema
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::503159affdfae1efff702ab43b09c70b
https://pubmed.ncbi.nlm.nih.gov/28860647
https://pubmed.ncbi.nlm.nih.gov/28860647
Publikováno v:
Nature reviews. Drug discovery. 16(5)
Growing access to diverse 'real-world' data sources is enabling new approaches to close persistent evidence gaps about the optimal use of medical products in real-world practice. Here, we argue that contrary to widespread impressions, existing FDA re
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::30eaf0c5e5fe8a324497085593aef971
https://pubmed.ncbi.nlm.nih.gov/28232726
https://pubmed.ncbi.nlm.nih.gov/28232726
Publikováno v:
Expert Opinion on Orphan Drugs. 1:507-510
The United States Food and Drug Administration (FDA) has long recognized the key role it plays in ensuring patients have timely access to safe and effective drugs. Over the past 25 years, FDA has developed multiple programs, including Fast Track, Acc
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::a61a29fbffdcde45aa0b7e71fa5d5639
https://doi.org/10.1517/21678707.2013.805124
https://doi.org/10.1517/21678707.2013.805124
Autor:
Danica Marinac-Dabic, Thomas G. Gross, Lisa M. LaVange, Gerry W. Gray, Lilly Q. Yue, Robert Temple, Jeffrey Shuren, Janet Woodcock, Steven A. Anderson, Melissa A. Robb, Nina L. Hunter, Robert M. Califf, Peter W. Marks, Gerald J. Dal Pan, Rachel E. Sherman
Publikováno v:
The New England journal of medicine. 375(23)
The FDA is developing guidance on the use of “real-world evidence” — health care information from atypical sources, including electronic health records, billing databases, and product and disease registries — to assess the safety and effectiv
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::76a0bd336ebd21613a33ee7b5bb15d44
https://pubmed.ncbi.nlm.nih.gov/29733448
https://pubmed.ncbi.nlm.nih.gov/29733448
Publikováno v:
JAMA. 316(23)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3abe2179a5adcded6da04d0dfeea8f3d
https://pubmed.ncbi.nlm.nih.gov/27820637
https://pubmed.ncbi.nlm.nih.gov/27820637
Autor:
Rachel E. Sherman, Judith M. Kramer, Leslie Ball, Martin J Landray, Briggs W. Morrison, Cheryl Grandinetti
Publikováno v:
Drug Information Journal. 46:657-660
This article is the version submitted to the publisher which was accepted without revision.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7ce9b427c1c6e367a7e52df211db16ee
https://doi.org/10.1177/0092861512464372
https://doi.org/10.1177/0092861512464372
Publikováno v:
Health Affairs. 31:2188-2192
As norms of comparative effectiveness research are sought within the biomedical and health care communities, and the science of conducting and interpreting this research develops, the Food and Drug Administration (FDA) must balance diverse interests.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3694650086abc1db4be6aac053a54c0f
https://doi.org/10.1377/hlthaff.2012.0958
https://doi.org/10.1377/hlthaff.2012.0958
Autor:
Rachel E. Sherman, Deborah A. Zarin, Judith M. Kramer, Robert M. Califf, Asba Tasneem, Laura H. Aberle
Publikováno v:
Jama : Journal of the American Medical Association, 307, 1838-47
Jama : Journal of the American Medical Association, 307, 17, pp. 1838-47
Jama : Journal of the American Medical Association, 307, 17, pp. 1838-47
Item does not contain fulltext CONTEXT: Recent reports highlight gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations. Strengthened reporting requirements for studies registered
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fa4c725628828dc1610e4ae0cd4e2c7c
https://hdl.handle.net/2066/110529
https://hdl.handle.net/2066/110529