In the USA, drugs are approved by the FDA by three main regulatory
pathways: (i) 505(b)(1) new drug applications (NDAs); (ii) 505(b)(2) NDAs;
and (iii) 505(j) abbreviated NDAs (ANDAs). The appropriate pathway
depends on the active ingredient, already approved drug products, drug
formulation, clinical indication, route of exposure, among other factors.
The 505(b)(2) NDA pathway is a regulatory approval pathway that allows
sponsors to use existing public data in lieu of conducting studies; thus,
potentially offering significant drug development and marketing
advantages. Nonclinical testing programs for 505(b)(2) submissions are
often reduced and, in some cases, are not even required. This paper
provides an overview of the 505(b)(2) regulatory pathway with a focus on
how nonclinical programs can be streamlined and accelerated.