Draft Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval; Availability; Reopening of Comment Period

摘要

The Food and Drug Administration (FDA) is reopening until February 8, 2008, the comment period for the draft guidance for industry entitled "Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval," published in the Federal Register of October 15, 2007 (72 FR 58312). The draft guidance informed industry of FDA's current thinking regarding appropriate clinical study designs to evaluate antibacterial drugs, and asked sponsors to amend ongoing or completed studies accordingly. FDA is taking this action in response to a request for an extension of the comment period to allow interested persons additional time to review the draft guidance and submit comments.