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Guidance for Antibacterial Therapies

07/08/2013

Federal Register Notice: FDA is making available a draft guidance for industry entitled Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases. Its purpose is to assist sponsors in developing a new antibacterial drugs to treat serious bacterial diseases, particularly in areas of unmet need, and new antibacterial drugs that are pathogen-focused (i.e., drugs that have a narrow spectrum of activity or are only active against a single genus or species of bacteria). To download the draft guidance, click here. To view this notice, click here.

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