This guidance does not provide recommendations for the use of NI study designs to evaluate the safety of a drug.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidance documents means suggested or recommended, but not required.
This guidance finalizes the draft guidance for industry, Non-Inferiority Clinical Trials, published in 2010. In addition, it supersedes the guidance for industry, Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval, also published in 2010, which will be withdrawn.