NEW YORK, May 26, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
This report provides in depth analysis of the current and evolving regulatory framework for drugs and diagnostics in the US and EU and specific guidance for their co-development. Advances in biomarker development and validation are assessed and case studies given of regulatory approvals of drugs and companion tests. Strategies for drug-diagnostic co-development are evaluated.
Features and benefits
* Understand the current regulatory environment for both diagnostics and drugs within the EU and the US and how these relate to their co-development.
* Understand the biomarker discovery and validation process.
* Using case studies discover how drugs and their companion diagnostics have already received approval in the US and EU.
* Discover the various types of collaborations used by pharma and diagnostic companies.
* Assess the impact of drug-diagnostic co-development on key stakeholders including the industry, regulators, physicians, and pharmacy benefit managers.
The regulatory landscape for drug-diagnostic co-development projects is evolving. The FDA and EMA both have similar biomarker qualification processes in place that enable companies to obtain advice or qual