- Docket Number:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research, Office of New Drugs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers (Revision 1).” The purpose of this draft guidance is to assist sponsors in the clinical development of new antibacterial drugs, and it provides updates to the options for development programs, given the availability of some new therapeutic options. This draft guidance will provide necessary updates to the final guidance entitled “Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases” published on August 2, 2017.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-D-0744.