Literature DB >> 26448898

FDA's Proposed Guidance for Laboratory Developed Tests: How Should Regulators Balance the Risks and Promise of Innovation in Clinical Genetics?

Michelle Bayefsky1, Benjamin E Berkman1.   

Abstract

Entities:  

Year:  2015        PMID： 26448898      PMCID： PMC4593508     

Source DB:  PubMed          Journal:  FDLIs Food Drug Policy Forum        ISSN： 2159-0893


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  16 in total

1.  FDA regulation of genetic testing: institutional reluctance and public guardianship.

Authors:  A Huang
Journal:  Food Drug Law J       Date:  1998       Impact factor: 0.619

2.  Which way for genetic-test regulation? Leave test interpretation to specialists.

Authors:  Arthur L Beaudet
Journal:  Nature       Date:  2010-08-12       Impact factor: 49.962

3.  The need for increased oversight of genetic testing: a detailed look at the genetic testing process.

Authors:  David C Bonnin
Journal:  Houst J Health Law Policy       Date:  2003

4.  First FDA authorization for next-generation sequencer.

Authors:  Francis S Collins; Margaret A Hamburg
Journal:  N Engl J Med       Date:  2013-11-19       Impact factor: 91.245

5.  A new initiative on precision medicine.

Authors:  Francis S Collins; Harold Varmus
Journal:  N Engl J Med       Date:  2015-01-30       Impact factor: 91.245

6.  Regulation of next generation sequencing.

Authors:  Gail H Javitt; Katherine Strong Carner
Journal:  J Law Med Ethics       Date:  2014       Impact factor: 1.718

7.  A public health perspective on research ethics.

Authors:  D R Buchanan; F G Miller
Journal:  J Med Ethics       Date:  2006-12       Impact factor: 2.903

Review 8.  Molecular genetic testing and the future of clinical genomics.

Authors:  Sara Huston Katsanis; Nicholas Katsanis
Journal:  Nat Rev Genet       Date:  2013-06       Impact factor: 53.242

9.  Retention of medical genetics knowledge and skills by medical students.

Authors:  Anne E Greb; Simone Brennan; Lori McParlane; Renee Page; Patrick D Bridge
Journal:  Genet Med       Date:  2009-05       Impact factor: 8.822

10.  A standardized framework for the validation and verification of clinical molecular genetic tests.

Authors:  Christopher J Mattocks; Michael A Morris; Gert Matthijs; Elfriede Swinnen; Anniek Corveleyn; Els Dequeker; Clemens R Müller; Victoria Pratt; Andrew Wallace
Journal:  Eur J Hum Genet       Date:  2010-07-28       Impact factor: 4.246
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