Linked Life Data

12049094

Source:http://linkedlifedata.com/resource/pubmed/id/12049094

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
105
pubmed:dateCreated
2002-6-5
pubmed:abstractText
The Food and Drug Administration (FDA) is amending its new drug and biological product regulations to allow appropriate studies in animals in certain cases to provide substantial evidence of the effectiveness of new drug and biological products used to reduce or prevent the toxicity of chemical, biological, radiological, or nuclear substances. This rule will apply when adequate and well-controlled clinical studies in humans cannot be ethically conducted and field efficacy studies are not feasible. In these situations, certain new drug and biological products that are intended to reduce or prevent serious or life-threatening conditions may be approved for marketing based on evidence of effectiveness derived from appropriate studies in animals and any additional supporting data.
pubmed:keyword
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
E
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
May
pubmed:issn
0097-6326
pubmed:author
pubmed:issnType
Print
pubmed:day
31
pubmed:volume
67
pubmed:owner
HSR
pubmed:authorsComplete
Y
pubmed:pagination
37988-98
pubmed:dateRevised
2011-11-17
pubmed:meshHeading
pubmed:year
2002
pubmed:articleTitle
New drug and biological drug products; evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible. Final rule.
pubmed:publicationType
Journal Article