Final Guidance On Non-Inferiority Studies Lacks Industry-Sought Changes

Despite industry's concerns about a "vaguely" defined M2 clinical margin in a 2010 draft guidance on non-inferiority, FDA has stood pat in its wording.

Several major industry players, including the Pharmaceutical Research and Manufacturers of America, AstraZeneca PLCand Pfizer Inc. commented that the meaning of the M2 margin – defined in the draft guidance as the largest clinically acceptable difference (degree of inferiority) of the test drug compared to the active control – is both unclear and subjective