Public health preparedness: Medical countermeasure development for certain serious or life-threatening conditions : report to congressional committees

Public health preparedness: Medical countermeasure development for certain serious or life-threatening conditions : report to congressional committees

Collection:
Health Policy and Services Research
Alternate Title(s):
Medical countermeasure development for certain serious or life-threatening conditions: report to congressional committees
Contributor(s):
United States. Government Accountability Office, issuing body.
United States. Congress, issuing body.
Publication:
Washington, DC : United States Government Accountability Office, June 2022
Language(s):
English
Format:
Text
Subject(s):
Bioterrorism
Disaster Medicine -- organization & administration
Disease Models, Animal
Government Regulation
United States
Genre(s):
Technical Report
Abstract:
Why GAO did this study. Past bioterrorist attacks, such as the anthrax attacks of 2001, highlight the threat of widespread illness and death posed by CBRN agents and the importance of medical countermeasures. GAO has previously reported on the challenges of developing medical countermeasures. Medical countermeasures may need to be developed and approved under FDA’s Animal Rule. The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 included a provision for GAO to review medical countermeasure development under the Animal Rule. In this report GAO describes (1) FDA efforts to support medical countermeasure developers under the Animal Rule, and (2) the extent of animal model qualification under FDA’s Animal Model Qualification Program, and the effect of qualified models on medical countermeasure development. GAO reviewed FDA documentation, including agency medical countermeasure development guidance. GAO also interviewed or obtained written responses from FDA officials; other federal agencies involved in medical countermeasure development; and a nongeneralizable selection of six developers, three contract research organizations and four academic research and policy organizations. GAO selected interviewees based on their involvement in or knowledge of medical countermeasure development under the Animal Rule. HHS and the Department of Defense provided technical comments, which GAO incorporated as appropriate.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (ii, 25 pages))
Illustrations:
Illustrations
NLM Unique ID:
9918470885706676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918470885706676