Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval November 2010
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
The purpose of this guidance is to inform industry of the Food and Drug Administration’s (FDA’s) current thinking regarding appropriate clinical trial designs to evaluate antibacterial drug products, and to provide an opportunity for sponsors to amend ongoing or completed trials accordingly. This guidance is in response to a number of public discussions in recent years regarding the use of active-controlled trials designed to show noninferiority (NI) as a basis for approval of antimicrobial drug products. These discussions initially focused on the indications acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and acute bacterial otitis media (ABOM). However, the science of active-controlled trials designed to show NI and the selection of appropriate NI margins in circumstances where an activecontrolled trial designed to show NI is an appropriate trial design has been a focus of recent discussions in other antimicrobial drug product indications and in other therapeutic areas as well.
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-2007-D-0150.