Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

摘要

The Food and Drug Administration (FDA or we) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (the committee). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The committee will discuss considerations related to the use of pertussis controlled human infection models (CHIMs) in pivotal studies to demonstrate efficacy of pertussis vaccines for the purpose of licensure and will hear an overview of the Laboratory of Mucosal Pathogens and Cellular Immunology (LMPCI) research program in the Center for Biologics Evaluation and Research (CBER). At least one portion of the meeting will be closed to the public. FDA is establishing a docket for public comment on this document.