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Developing Rabies Monoclonal Antibody Products as a Component of Rabies Post-Exposure Prophylaxis; Public Workshop; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop regarding development of rabies monoclonal antibody products to be used in conjunction ...

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop regarding development of rabies monoclonal antibody products to be used in conjunction with licensed rabies vaccine as part of a rabies post-exposure prophylaxis (PEP) regimen. This public workshop is intended to provide information for, and gain perspective from, health care providers, other U.S. Government Agencies, academic experts, industry, and other stakeholders on various aspects of development efforts pertaining to animal models, laboratory assays, and clinical trials.

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82 FR 26494

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“Developing Rabies Monoclonal Antibody Products as a Component of Rabies Post-Exposure Prophylaxis; Public Workshop; Request for Comments,” thefederalregister.org (June 7, 2017), https://thefederalregister.org/documents/2017-11820/developing-rabies-monoclonal-antibody-products-as-a-component-of-rabies-post-exposure-prophylaxis-public-workshop-reques.