Title of Collaborative Activity: |
Predictive Biodosimetry Guidance Planning Working Group |
Description of Collaborative Activity: |
Working group meets monthly with the following goals: 1) Convene a subject matter expert (SME) panel to discuss target product profile (TPP) or device/assay specifications for predictive biodosimetry in early 2021; 2) Identify key SMEs. trans-agency partners and companies; 3) Host meeting, write panel consensus report; 4) Partner with FDA to generate an addendum to the Biodosimetry Guidance; 5) Identify pathways for development and potential pitfalls; 6) Identify funding to support mid-stage to advanced development of predictive biodosimetry devices/assays. |
Type of Collaborative Activity: |
Committee, Advisory Group, or Work Group
|
Year the Collaborative Activity Originated: |
2020 |
NIH Participating Institutes/Centers/Office of the Director: |
NIAID |
HHS Agency Collaborators on this Activity: |
ASPR, FDA |
