In the May 31, 2016, Federal Register, FDA announced an upcoming public workshop regarding antibacterial drug development for patients with unmet need and developing antibacterial drugs that target a single species. Discussions will focus on potential development pathways; aspects of clinical trials, including patient population; trial designs and endpoints; and the role of clinical trial networks in antibacterial drug development. FDA will post a draft agenda before the meeting and invites individuals, industry, health care professionals, researchers, public health organizations, and other interested persons to attend. Input from this public workshop will also help in developing topics for future discussion. The public workshop will be held July 18 and 19, 2016.
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