Linked Life Data

16972706

Source:http://linkedlifedata.com/resource/pubmed/id/16972706

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
2006-9-15
pubmed:abstractText
This article describes the motivation for, description of, and the objectives and plans for the FDA's initiative that was introduced in March of 2004 by way of a report titled 'Innovation or Stagnation?--Challenge and Opportunity on the Critical Path to New Medical Products'. The FDA initiative is very much an outreach effort and a wake-up call to many constituencies to contribute and partner to improve the product development process and thereby to contribute to the success rate of new products that will benefit the public. We discuss in general terms where some of the opportunities and challenges exist for the discipline of biostatistics to make contributions to this effort over the next few years. In particular, guidance development in five areas is considered as is the need to devote new energy and efforts to quantitative risk assessment and safety evaluation, an area that has lagged the attention received in the efficacy evaluation area.
pubmed:commentsCorrections
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:month
Aug
pubmed:issn
0323-3847
pubmed:author
pubmed:issnType
Print
pubmed:volume
48
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
559-64
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
2006
pubmed:articleTitle
FDA's critical path initiative: a perspective on contributions of biostatistics.
pubmed:affiliation
Office of Biostatistics, OTS/CDER/FDA, 10903 New Hampshire Avenue, Bldg 22, Room 6012, Silver Spring, MD 20993-0002, USA. oneill@cder.fda.gov
pubmed:publicationType
Journal Article