Home » Discussion Topics and Assigned Readings » Apr 7, 2021: FDA Oversight of Genetic Testing

Apr 7, 2021: FDA Oversight of Genetic Testing

Assigned Readings

  • Milkey et al. FDA oversight of NSIGHT genomic research: the need for an integrated systems approach to regulation.  npj Genomic Medicine 2019 (4): 32. Article link.
  • JD Supra. FDA Oversight of Laboratory-Developed Tests Continues To Evolve.  Available here. (Oct 3, 2020)
  • Luh F, Yen . FDA guidance for next generation sequencing-based testing: balancing regulation and innovation in precision medicine.  FDA guidance for next generation sequencing-based testing: balancing regulation and innovation in precision medicine.  npj Genomic Medicine (2018) 3:28. Article link.

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