Opinion ID: 70441
Heading Depth: 2
Heading Rank: 2

Heading: Prior Approval Process

Text: Nor does anything in the FDCA or Hatch-Waxman Amendments explicitly forbid generic manufacturers from proposing a label change through the so-called prior approval process. [103] While FDA regulations provide for permissive use of the CBE process for warning enhancements, and the prior approval process is required for major changes, there is no indication of an agency policy, let alone congressional intent, to prevent generic manufacturers from proposing any and all labeling changesno matter the significance of the changethrough the prior approval process. Rather, the regulations governing labeling changes repeatedly use the nonrestrictive phrase [t]hese changes include, but are not limited to in describing the changes manufacturers may propose through each type of supplement. [104] Indeed, manufacturers are required to use the prior approval process for most labeling changes. [105]