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Animal Model Development Workshop

Animal Model Development Workshop

17-18 September, 2012
Bethesda, MD


The National Institute of Allergy and Infectious Diseases (NIAID), the Food and Drug Administration (FDA), the Transformational Medical Technologies (TMT), and Biomedical Advanced Research and Development Authority (BARDA) are holding an Animal Model Development Workshop to explore the scientific and regulatory challenges of developing medical countermeasures (MCM) under the "Animal Rule” (21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products).

The goals of this workshop are to highlight the significant progress made in animal model development for MCMs, review recent case studies of products under development using animal models, and capture lessons learned to inform future animal model development efforts. In addition, the workshop will provide a forum to discuss current challenges and identify potential solutions or mitigation strategies.


Meeting VideoCast

Federal Register Notice



Final Workshop Agenda









Last Updated September 26, 2012

Last Reviewed September 26, 2012