| Drug-diagnostic codevelopment strategies: FDA and industry dialog at the 4th FDA/DIA/PhRMA/PWG/BIO Pharmacogenomics Workshop. | |
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MedLine Citation:
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PMID: 19102722 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The 4th US FDA/Industry Workshop on Pharmacogenomics in Drug Development and Regulatory Decision Making, was held in MD, USA, on December 10-12, 2007. One of the breakout sessions of the workshop focused on the regulatory issues around codevelopment of drugs and companion diagnostics. This session used hypothetical case studies as focal points for discussion of current thought and critical issues for both industry and the FDA in this evolving field. The panel and the audience discussed the evolution of the FDA's thinking on the regulatory path for companion diagnostics since the release of the April 2005 draft Drug Test Codevelopment Concept Paper and the issues faced by industry in attempting codevelopment efforts. This session provided an opportunity to allow an exchange of ideas between the FDA and industry and to identify critical issues that need further discussion in this important and evolving field. |
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Authors:
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Lois Hinman; Brian Spear; Zenta Tsuchihashi; James Kelly; Peter Bross; Federico Goodsaid; Francis Kalush |
Publication Detail:
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Type: Congresses |
Journal Detail:
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Title: Pharmacogenomics Volume: 10 ISSN: 1744-8042 ISO Abbreviation: Pharmacogenomics Publication Date: 2009 Jan |
Date Detail:
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Created Date: 2008-12-23 Completed Date: 2009-03-23 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100897350 Medline TA: Pharmacogenomics Country: England |
Other Details:
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Languages: eng Pagination: 127-36 Citation Subset: IM |
Affiliation:
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Novartis Pharmaceuticals Corp, One Health Plaza, East Hanover, NJ 07939-1080, USA. lois.hinman@novartis.com |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Clinical Trials as Topic*
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standards Decision Making* Diagnostic Techniques and Procedures* / standards Drug Design* Drug Industry* / standards Humans Pharmacogenetics* / standards Policy Making United States United States Food and Drug Administration |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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