The clinical studies needed to support receiving approval to market the old drug for a new indication, as well as whatever lifecycle management and post-marketi

The clinical studies needed to support receiving approval to market the old drug for a new indication, as well as whatever lifecycle management and post-marketing surveillance activities (Phase IV) that are required. The alternate indications may be well-known but marketing for an off label indication is not permitted (as in, they actually jail CEOs and executives for that).