ABSTRACT
Bioavailability (BA) and bioequivalence (BE) studies are expensive to conduct and given the
need for a multitude of these studies in the development of a new drug application (NDA) or
abbreviated new drug application (ANDA), there had always existed a need to justify these
needs on scientific grounds. This is particularly important for the generic drug industry since
the generic competitors must keep their cost of regulatory approval to as low a level as possible.
Recently, guidelines have emerged that would allow waiver of both BA and BE studies in some
situations. There are also provisions available for the sponsor to challenge the requirement and
if the basic criteria set are met, there is a very good possibility of receiving waivers. These
waivers are intended to apply to
