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FDA on antimicrobials

This article was originally published in The Rose Sheet

Executive Summary

Reopening comment period for two guidance documents on developing antimicrobials until Jan. 29, the agency announced in the Federal Register Nov. 4. FDA received comments asking for additional time to review both documents. The July 21 and July 29 guidances were originally granted a 90-day review period. One notice requests comments on FDA's process for "developing and using guidance documents" on antimicrobial drug product development. The second announces the availability of a general draft guidance for industry entitled "Developing Antimicrobial Drugs - General Considerations for Clinical Trials" and 17 draft guidelines on developing antimicrobials to treat individual indications
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