Controlled Correspondence Related to Generic Drug Development; Guidance for Industry; Availability
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final 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's controlled correspondence response and the Agency's process for responding to those requests. This guidance finalizes the draft guidance of the same title issued on December 22, 2022. This guidance replaces the guidance "Controlled Correspondence Related to Generic Drug Development" issued on December 17, 2020.
Abstract as published in the Federal Register.
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