Setting the Stage – A Brief History of FDA Regulation of Precision Medicine, and a Glimpse to its Possible Future


Precision Medicine occupies a complex space – driven by science, dependent upon third parties for financial support, and bounded by vague and emerging laws and regulations that may have outsized influence over its clinical and commercial success. The Journal of Precision Medicine provides valuable in-depth educational content and actionable business intelligence to stakeholders in this rapidly growing field, but to date there has been only ad hoc coverage of one of the most significant elements impacting Precision Medicine – namely, governmental regulation and policies and their impact (good and bad) on the players and products of this emerging medical revolution. To further round out the coverage of the Journal I have been invited to contribute a regular column covering the legal, regulatory and public policy issues affecting Precision Medicine.

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