To obtain drug approval from the US Food and Drug
Administration (FDA), manufacturers must establish efficacy
by providing “substantial evidence” of effectiveness from
“adequate and well‐controlled studies.” In November 2016,
the FDA issued a final guidance for industry, Non-Inferiority
Clinical Trials to Establish Effectiveness, to provide advice on
the appropriate use of NI study designs for investigational
drugs or biologics. In her article, Deborah A. Komlos, MS,
Senior Medical & Regulatory Writer for the Cortellis
Regulatory Intelligence US Module at Clarivate Analytics,
explains the changes which have been made in this current
guidance.