Society News Archive

30 December 2014
Comments Wanted on FDA Draft Guidance: "Radiation Biodosimetry Devices"

The Food and Drug Administration has announced the availability of the draft guidance "Radiation Biodosimetry Devices." The draft guidance provides recommendations to assist industry in designing studies to establish the analytical and clinical performance characteristics of radiation biodosimetry medical countermeasure devices. This draft guidance is not final nor is it in effect at this time.

Comments on the draft guidance should be submitted before 30 March 2015.