DUBLIN--(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.)--Research and Markets (
“Assessing the U.S. Regulatory Landscape for Diagnostic Testing”
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an active role in encouraging the development and use of biomarker-based diagnostics by publishing revised updates and draft guidance.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
- 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
For more information visit http://www.researchandmarkets.com/research/jpsjhx/assessing_the_u_s
Source: Decision Resources, Inc