Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Controlled Correspondence Related to Generic Drug Development.'' This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency's process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA' controlled correspondence response and the Agency's process for responding to those requests. This draft guidance revises the guidance for industry ``Controlled Correspondence Related to Generic Drug Development'' issued in September 2015.