|
rdf:type |
|
|
lifeskim:mentions |
|
|
pubmed:issue |
6
|
|
pubmed:dateCreated |
2010-6-1
|
|
pubmed:abstractText |
Heterogeneity in the underlying mechanisms of disease processes and inter-patient variability in drug responses are major challenges in drug development. To address these challenges, biomarker strategies based on a range of platforms, such as microarray gene-expression technologies, are increasingly being applied to elucidate these sources of variability and thereby potentially increase drug development success rates. With the aim of enhancing understanding of the regulatory significance of such biomarker data by regulators and sponsors, the US Food and Drug Administration initiated a programme in 2004 to allow sponsors to submit exploratory genomic data voluntarily, without immediate regulatory impact. In this article, a selection of case studies from the first 5 years of this programme - which is now known as the voluntary exploratory data submission programme, and also involves collaboration with the European Medicines Agency - are discussed, and general lessons are highlighted.
|
|
pubmed:language |
eng
|
|
pubmed:journal |
|
|
pubmed:citationSubset |
IM
|
|
pubmed:chemical |
|
|
pubmed:status |
MEDLINE
|
|
pubmed:month |
Jun
|
|
pubmed:issn |
1474-1784
|
|
pubmed:author |
pubmed-author:AmurShashiS,
pubmed-author:AubrechtJiriJ,
pubmed-author:BurczynskiMichael EME,
pubmed-author:CarlKevinK,
pubmed-author:CatalanoJenniferJ,
pubmed-author:CharlabRosaneR,
pubmed-author:CloseSandraS,
pubmed-author:Cornu-ArtisCatherineC,
pubmed-author:EssiouxLaurentL,
pubmed-author:FornaceAlbert JAJJr,
pubmed-author:FuZhenZ,
pubmed-author:GoodsaidFederico MFM,
pubmed-author:HinmanLoisL,
pubmed-author:HongHuixiaoH,
pubmed-author:HuntIanI,
pubmed-author:Jacobson-KramDavidD,
pubmed-author:JawaidAnsarA,
pubmed-author:LaurieDavidD,
pubmed-author:LeskoLawrenceL,
pubmed-author:LiHeng-HongHH,
pubmed-author:LindpaintnerKlausK,
pubmed-author:MorrowPeterP,
pubmed-author:Papaluca-AmatiMarisaM,
pubmed-author:RobisonTimothy WTW,
pubmed-author:RothJohnJ,
pubmed-author:Schuppe-KoistinenInaI,
pubmed-author:ShiLemingL,
pubmed-author:SpleissOliviaO,
pubmed-author:TongWeidaW,
pubmed-author:TruterSharada LSL,
pubmed-author:VonderscherJackyJ,
pubmed-author:WestelinckAgnesA,
pubmed-author:ZhangLiL,
pubmed-author:ZinehIssamI
|
|
pubmed:issnType |
Electronic
|
|
pubmed:volume |
9
|
|
pubmed:owner |
NLM
|
|
pubmed:authorsComplete |
Y
|
|
pubmed:pagination |
435-45
|
|
pubmed:meshHeading |
pubmed-meshheading:20514070-Alanine Transaminase,
pubmed-meshheading:20514070-Azetidines,
pubmed-meshheading:20514070-Benzylamines,
pubmed-meshheading:20514070-Carcinoma, Renal Cell,
pubmed-meshheading:20514070-Drug Approval,
pubmed-meshheading:20514070-Europe,
pubmed-meshheading:20514070-Fluorouracil,
pubmed-meshheading:20514070-Gene Expression Profiling,
pubmed-meshheading:20514070-Genetic Markers,
pubmed-meshheading:20514070-Humans,
pubmed-meshheading:20514070-Individualized Medicine,
pubmed-meshheading:20514070-International Cooperation,
pubmed-meshheading:20514070-Kidney Neoplasms,
pubmed-meshheading:20514070-Kidney Transplantation,
pubmed-meshheading:20514070-Pharmacogenetics,
pubmed-meshheading:20514070-Piperazines,
pubmed-meshheading:20514070-Thiophenes,
pubmed-meshheading:20514070-United States,
pubmed-meshheading:20514070-United States Food and Drug Administration
|
|
pubmed:year |
2010
|
|
pubmed:articleTitle |
Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact.
|
|
pubmed:affiliation |
Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA, Building 51, 10903 New Hampshire Avenue, Silver Spring, Maryland 20903-002, USA. Federico.Goodsaid@fda.hhs.gov
|
|
pubmed:publicationType |
Journal Article
|
