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Regulation

The cutting edge technologies used in personalized medicine often do not fit the mold of the existing regulatory pathway. Personalized medicine may work in smaller, targeted populations or require the use of a companion diagnostic. Therefore, the benefit of these therapeutics may be shown quickly through the use of biomarker data rather than traditional long-term clinical trial outcomes. Conversely, the research required to validate biomarkers can be very complex and time consuming. The regulatory system must continue to evolve and adapt to advancing science to make the process predictable for companies and efficient for patients.

Through efforts such as the Critical Path Initiative and voluntary genomic data submissions, FDA has taken important steps to ensure its regulatory policies keep up to date with the science of personalized medicine.

To continue to support personalized medicine through regulatory processes:

  • The development and utilization of biomarkers should be expanded through public-private partnerships, such as the Biomarkers Consortium.
  • The development and use of new trial designs (such as adaptive designs and designs for targeted populations and sub-populations based on genetic markers or specifically defined and measured disease states) should be explored and encouraged.
  • The development of a clear path through FDA regulation for companion diagnostics should be defined.

Additional Resources