Linked Life Data

3316417

Source:http://linkedlifedata.com/resource/pubmed/id/3316417

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
1987-12-31
pubmed:abstractText
Evaluating new antimicrobial agents is governed mostly by interaction between the pharmaceutical industry and the Food and Drug Administration (FDA). Clinical trials are designed to comply with FDA guidelines published in 1977. Basic principles of the 1977 guidelines remain valid; however, changes in the clinical application of anti-infective agents and in the accepted design of clinical trials have occurred. Some changes are inconsistent with the requirements of the 1977 documents. Members of the Infectious Diseases Society of America (IDSA) have the perspective and knowledge needed to assist in updating the 1977 guidelines. It is proposed that the IDSA establish a formal working relationship with the FDA to review and modernize the 1977 guidelines. Industry participation in this process is desirable. If the IDSA can help orchestrate guideline revision in an environment of mutual respect and cooperation, the result may be a more efficient drug-evaluation process that continues to protect the public interest and is more consistent with contemporary concepts of treatment for infectious disease.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
AIM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Dec
pubmed:issn
0022-1899
pubmed:author
pubmed:issnType
Print
pubmed:volume
156
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
934-41
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
1987
pubmed:articleTitle
Guidelines for evaluating new antimicrobial agents.
pubmed:affiliation
Chiles Research Institute, Providence Medical Center, Portland, Oregon 97213.
pubmed:publicationType
Journal Article, Clinical Trial, Review