The African Green Monkey Model of Pneumonic Plague and US Food and Drug Administration Approval of Antimicrobials Under the Animal Rule
Abstract
Additional treatment options for pneumonic plague, the most severe form of infection by Yersinia pestis, are needed, as past US Food and Drug Administration (FDA) approvals were not based on clinical trials that meet today’s standards, and multiple drugs are sought to counter resistance or use in special populations. Due to the sporadic nature of outbreaks and the low number of pneumonic cases of disease, we sought FDA approval of antimicrobials for treatment under the Animal Efficacy Rule, where efficacy can be demonstrated in 1 or more well-characterized animal models that sufficiently represent human disease.
Document Details
- Document Type
- Pub Defense Publication
- Publication Date
- May 01, 2020
- Source ID
- 10.1093/cid/ciz1233
Entities
People
- Joseph L Campbell
- Judith A Hewitt
- Lynda L Lanning
Organizations
- Lovelace Respiratory Research Institute
- National Institute of Allergy and Infectious Diseases
- United States Army Medical Research Institute of Infectious Diseases