FDA Releases Report on Personalized Medicine

The report describes the concept and various definitions of personalized medicine and notes that it typically involves both a diagnostic device (e.g., assays to measure genetic factors and imaging equipment) and a therapeutic product. FDA’s role and responsibilities in this field include considering benefits and risks when evaluating medical products, providing guidance to encourage development, being informed about advances and ensuring that information is used appropriately throughout the industry, and working with stakeholders to evaluate and validate new diagnostics and therapeutics. FDA is responsible for “identifying opportunities for streamlining regulatory processes and advancing the science and tools that will help drive innovation,” notes the report. 

For further details, see FDA

Posted by Tim Sandle