Federal Register Notice: FDA is reopening until 2/8 the comment period for the draft guidance for industry, Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval, published in the 10/15/07 Federal Register. It informed industry of the agency’s current thinking on appropriate clinical study designs to evaluate antibacterial drugs, and asked sponsors to amend ongoing or completed studies accordingly. To view this notice, click here.
