Regulatory of Personalized medicine

The FDA is  already started to take initiatives to integrate personalized medicine into their regulatory policies.They developed a report in October 2013 entitled Paving the Way for Personalized Medicine FDAs role in a New Era of Medical Product Development in which they outlined steps they would have to take to integrate genetic and biomarker information for clinical use and drug development. They determined that they would have to develop specific regulatory science standards, research methods, reference material and other tools in order to incorporate personalized medicine into their current regulatory practices. For example, they are working on a genomic reference library for regulatory agencies to compare and test the validity of different sequencing platforms in an effort to uphold reliability.

  • FDA and Personalized medicine
  • Regulatory aspects of pharmacogenetics
  • FDA and predictive medicine
  • FDA and validation of biomarkers

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