This guidance provides information regarding the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development. This guidance also describes the Agency’s process for providing communications related to such correspondence.

This guidance replaces the September 2015 guidance for industry Controlled Correspondence Related to Generic Drug Development. The September 2015 guidance was issued as part of FDA’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA I). This guidance is being issued to incorporate program enhancements related to the review of controlled correspondence to which FDA committed, and industry agreed, as part of the reauthorization of GDUFA (GDUFA II).