Thursday, January 6, 2022

Very Brief Blog: Brookings Report on "Precision Medicine Through Agile Governance"

New report from Brookings to kick off January 2022, "Advancing precision medicine through agile governance."  Find it here:

There are three authors, Kevin Doxzen, Landry Signe', and Diana Bowman.  While applied to precision medicine, the work by Doxzen et al. tees off from previous writings by Landry Signe' on economics and agile governance in general - here.

If you like the topic of regulatory reform and agile governance, see also this paper:

  • Bridging the Gap: The critical role of regulatory affairs and clinical affairs in total product life in pathology imaging devices and software.  Kearney et al. (open accss) here.
  • Laboratory-developed tests in the new European Union 2017/746 regulation: opportunities and risks.  Vogeser et al. here.
  • Temporary regulatory deviations and the COVID PCR Labeling Update Study indicate what LDT regualtion by FDA could look like.   Marble et al. (open access) here.
  • National maintenance cost for precision diagnostics under VALID ACT of 2020.  Huang et al. here.