Federal Register :: Public Inspection: Meetings: Advancing Animal Models for Antibacterial Drug Development; Public Workshop

Federal Register :: Public Inspection: Meetings: Advancing Animal Models for Antibacterial Drug Development; Public Workshop

The Food and Drug Administration is announcing the public workshop titled “Advancing Animal Models for Antibacterial Drug Development.” The purpose of the public workshop is to discuss ongoing research efforts to advance the development of animal models of serious bacterial infection. FDA is holding this public workshop to discuss research results regarding the development of various animal models of serious infection funded by FDA, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), and to discuss ideas for future research in this area.

FDA is particularly interested in discussing challenges encountered in animal model development and ideas for future research.  Discussions will focus on the following topic areas:

• an overview of urinary tract infection, abdominal infection, and pneumonia animal models currently used in antibacterial drug development;
• pharmacokinetic considerations in animal model development;
• animal model resources and development supported by NIH;
• progress and challenges in advancement of murine (rodent), rabbit, and porcine (pig) models of serious bacterial infections supported by FDA and BARDA; and
• potential priorities for further research and development.

The public workshop will be held on March 5, 2020, from 8:30 a.m. to 4:00 p.m. at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. FDA encourages healthcare providers, industry, academic experts and other stakeholders to attend this public workshop. Registration for the public workshop is now open.

For more information about the meeting or to submit comments, please visit here.