Literature DB >> 25560381

FDA regulation of laboratory-developed diagnostic tests: protect the public, advance the science.

Joshua Sharfstein1.   

Abstract

Mesh:

Year:  2015        PMID: 25560381     DOI: 10.1001/jama.2014.18135

Source DB:  PubMed          Journal:  JAMA        ISSN: 0098-7484            Impact factor:   56.272


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  18 in total

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6.  The FDA and genomic tests--getting regulation right.

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8.  Cancer biomarker discovery and validation.

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Journal:  Transl Cancer Res       Date:  2015-06       Impact factor: 1.241

9.  The Limits of FDA's Authority to Regulate Clinical Research Involving High-Throughput DNA Sequencing.

Authors:  Barbara J Evans
Journal:  Food Drug Law J       Date:  2015       Impact factor: 0.619

10.  Gene-panel sequencing and the prediction of breast-cancer risk.

Authors:  Douglas F Easton; Paul D P Pharoah; Antonis C Antoniou; Marc Tischkowitz; Sean V Tavtigian; Katherine L Nathanson; Peter Devilee; Alfons Meindl; Fergus J Couch; Melissa Southey; David E Goldgar; D Gareth R Evans; Georgia Chenevix-Trench; Nazneen Rahman; Mark Robson; Susan M Domchek; William D Foulkes
Journal:  N Engl J Med       Date:  2015-05-27       Impact factor: 91.245

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