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Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval November 2010

Issued by:
Guidance Issuing Office
Center 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.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.