FDA final guidance: generic drug development

As part of the US Food and Drug Administration’s (FDA) commitment to ensuring current and prospective abbreviated new drug application (ANDA) applicants have the information they need to successfully submit high-quality ANDAs, the agency has finalized the guidance for industry, “ Controlled Correspondence Related to Generic Drug Development.”

This guidance provides information on agency communications related to controlled correspondence and how generic drug manufacturers and related industry can: submit controlled correspondence to FDA requesting information related to generic drug development; and submit requests to clarify ambiguities in the FDA’s controlled correspondence responses

This guidance replaces the December 2020 draft guidance, “Controlled Correspondence Related to Generic Drug Development.”