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Research and Markets: Assessing the U.S. Regulatory Landscape for Diagnostic Testing

2012年09月26日 AM02:13
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DUBLIN

Research and Markets (http://www.researchandmarkets.com/research/jpsjhx/assessing_the_u_s) has announced the addition of Decision Resources, Inc’s new report “Assessing the U.S. Regulatory Landscape for Diagnostic Testing” to their offering.

The FDA is taking an active role in encouraging the development and use of biomarker-based diagnostics by publishing revised updates and draft guidance. Such revisions will become increasingly important as new tests and technologies emerge. However, some recent changes have caused a fair amount of controversy among industry and researchers alike. The ability of regulators and stakeholders to reconcile their differences will be key to the industry’s continuing advancement.

Key Topics Covered:

– Executive Summary

– Strategic Considerations

– Stakeholder Implications

– Introduction

– New Frontiers in Diagnostic Testing

– Evolving Trends in Genetic Testing

– Continued Interest in Genetics Research

– Direct-to-Consumer Genetic Testing

– Current Regulatory Pathway Options for Diagnostics

– Diagnostic Kits 12

– In-House or Home-Brew Tests

– Broad Controversies in Diagnostics Regulation

– Premarket Notification Pathway Update or Revise?

– Research Only Products in Laboratory-Based Diagnostics In or Out?

– Ongoing Controversies in Genetic Test Regulation

– Regulatory Oversight of Genetic Tests

– Issues in DTC Genetic Testing

– Reconciliation for Future Progress

– Tables

– Figures

For more information visit http://www.researchandmarkets.com/research/jpsjhx/assessing_the_u_s

Source: Decision Resources, Inc

CONTACT

Research and Markets
Laura Wood, Senior Manager.
press@researchandmarkets.com
U.S.
Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Diagnostics

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