Regulatory Affairs

Regulatory Strategy for In Vitro Companion Diagnostic Devices

Final FDA Guidance for In Vitro Companion Diagnostics…
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FDA Breakthrough Therapy Designation: A Pathway for Expedited Drug Development

On July 9, 2012 the Food and Drug…
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New FDA Guidance – A Risk-Based Approach to Monitoring Clinical Trials

As clinical trials have become increasingly complex, clinical…
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