PSTC Related News & Events
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Upcoming Meetings of Interest
Organization |
Conference Information |
The Liver Meeting |
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Annual Meeting |
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Annual Meeting & ToxExpo |
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30th STP Annual Symposium |
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Cellular and Molecular Mechanisms of Toxicity The conference offers a unique and revitalized focus on the cutting-edge mechanistic toxicological research that underpins key innovations in environmental, pharmaceutical, and industrial sciences. The collegial atmosphere with programmed discussion sessions and opportunities for informal gatherings in the afternoons and evenings provides an avenue for scientists from different disciplines to brainstorm, network, and collaborate. |
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Federation of European |
EUROTOX 2011 Congress |
Regulatory Science News
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Summary and Link |
FDA Biomarker Qualification Guide Could Affect Reimbursement Inside Washington's FDA Week. Vol. 16, No.32 - August 13 2010 |
As FDA prepares to release its long-awaited biomarkers qualification guidance, some stakeholders are cautioning the agency that its approach to endpoint validation could have major repercussions across the healthcare industry and even affect the viability of obtaining reimbursement for certain products. The upcoming guidance will address the administrative procedures to validate biomarkers and will not include scientific clarifications. |
PMDA's Challenge to Accelerate Clinical Development and Review of New Drugs in Japan Clinical Pharmacology & Therapeutics 88, 454-457 - October 2010 |
In recent years, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has conducted several projects to shorten drug development and review times in Japan to resolve the "drug lag." Key to achieving this goal is greater involvement by the PMDA in drug development through enhancement of scientific consultation and improvement of the review process by reinforcing the operational system, including hiring more reviewers. We discuss here the current projects of the PMDA as well as future challenges. |