Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
2008-11-17
pubmed:abstractText
The off-label use of drugs in paediatrics is a common practice casting doubts on the adequate safety of drug therapy. Regulatory initiatives of European and national legislators aim to address this paucity of clinical drug trials in paediatrics through clarifying regulations and incentives in pharmaceutical law, thereby promoting an increase in the approval of paediatric drugs, the improvement of drug and thus treatment safety. This paper describes the present situation in paediatrics and the legal status of off-label use in pharmaceutical law, medical malpractice law and statutory health insurance law.
pubmed:language
ger
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:issn
1865-9217
pubmed:author
pubmed:issnType
Print
pubmed:volume
102
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
37-43
pubmed:meshHeading
pubmed:year
2008
pubmed:articleTitle
[Off-label use of drugs in paediatrics causes uncertainty].
pubmed:affiliation
Institut für Gesundheits- und Medizinrecht, Fachbereich Rechtswissenschaft, Universität Bremen. hart@uni-bremen.de
pubmed:publicationType
Journal Article, English Abstract