NIH Policies and Regulatory Pathways to U.S. FDA licensure: Strategies to Inform Advancement of Radiation Medical Countermeasures and Biodosimetry Devices.

ABSTRACT: The Radiation and Nuclear Countermeasures Program within the National Institute of Allergy and Infectious Diseases (NIAID), is tasked with the mandate of identifying biodosimetry tests to assess exposure and medical countermeasures (MCMs) to mitigate/treat injuries to individuals exposed to significant doses of ionizing radiation from a radiological/nuclear incident, hosted. To fulfill this mandate, the Radiation and Nuclear Countermeasures Program (RNCP), hosted a workshop in 2018 workshop entitled "Policies and Regulatory Pathways to U.S. FDA licensure: Radiation Countermeasures and Biodosimetry Devices." The purpose of the meeting was to facilitate the advancement of MCMs and biodosimetry devices by assessing the research devices and animal models used in preclinical studies; government

SUBMITTER: Satyamitra MM 

PROVIDER: S-EPMC9332884 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature