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rdf:type |
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lifeskim:mentions |
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pubmed:issue |
5
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pubmed:dateCreated |
2007-2-7
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pubmed:abstractText |
In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric trials. The program has been praised for creating incentives for studies in children and has been criticized as a "windfall" to the innovator drug industry. This critique has been a substantial part of congressional debate on the program, which is due to expire in 2007.
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pubmed:grant |
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pubmed:commentsCorrections |
http://linkedlifedata.com/resource/pubmed/commentcorrection/17284698-10469794,
http://linkedlifedata.com/resource/pubmed/commentcorrection/17284698-12457422,
http://linkedlifedata.com/resource/pubmed/commentcorrection/17284698-15126420,
http://linkedlifedata.com/resource/pubmed/commentcorrection/17284698-15136558,
http://linkedlifedata.com/resource/pubmed/commentcorrection/17284698-15343191,
http://linkedlifedata.com/resource/pubmed/commentcorrection/17284698-15483275,
http://linkedlifedata.com/resource/pubmed/commentcorrection/17284698-15483276,
http://linkedlifedata.com/resource/pubmed/commentcorrection/17284698-16249422,
http://linkedlifedata.com/resource/pubmed/commentcorrection/17284698-16434634,
http://linkedlifedata.com/resource/pubmed/commentcorrection/17284698-16436720,
http://linkedlifedata.com/resource/pubmed/commentcorrection/17284698-16598296,
http://linkedlifedata.com/resource/pubmed/commentcorrection/17284698-16968851
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pubmed:language |
eng
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pubmed:journal |
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pubmed:citationSubset |
AIM
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pubmed:status |
MEDLINE
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pubmed:month |
Feb
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pubmed:issn |
1538-3598
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pubmed:author |
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pubmed:issnType |
Electronic
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pubmed:day |
7
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pubmed:volume |
297
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
480-8
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pubmed:dateRevised |
2011-5-3
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pubmed:meshHeading |
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pubmed:year |
2007
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pubmed:articleTitle |
Economic return of clinical trials performed under the pediatric exclusivity program.
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pubmed:affiliation |
Department of Pediatrics, Duke Clinical Research Institute, Duke University, Durham, NC 27705, USA. jennifer.li@duke.edu
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pubmed:publicationType |
Journal Article,
Research Support, N.I.H., Extramural
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