@Hash80
The Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted on July 9, 2012.7 Section 1135 of FDASIA amended section 505(q) of the FD&C Act in two ways. First, it shortened from 180 days to 150 days FDA’s deadline for final Agency action on the petitions subject to section 505(q). Second, with the exceptions noted below, it expanded the scope of section 505(q) to include certain petitions related to 351(k) applications.