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GDUFA III Controlled Correspondence Enhancements

Controlled correspondence is a correspondence submitted to FDA by or on behalf of a generic drug manufacturer or related industry requesting information on a specific element of generic drug product development or concerning certain post-approval submission requirements. Historically, and under the terms of the GDUFA III commitment letter, a controlled correspondence may be submitted by or on behalf of a generic drug manufacturer or related industry prior to submitting an abbreviated new drug application (ANDA). 

Under the GDUFA II framework, correspondence seeking regulatory and/or scientific advice after issuance of a Complete Response Letter or tentative approval, or after ANDA approval, was considered general correspondence. Under GDUFA III, these types of correspondence can be submitted as controlled correspondence. Also, under the terms of the GDUFA III commitment letter, during an ANDA assessment cycle, a controlled correspondence may be submitted if an applicant seeks further feedback after a product-specific guidance teleconference or to seek a Covered Product Authorization. During an ANDA assessment cycle, all other correspondence will be general correspondence.

The GDUFA III commitment letter provides additional information about controlled correspondence program enhancements, including definition updates and revised timelines for responding to controlled correspondence.

This page provides assistance on the important elements in GDUFA III regarding controlled correspondence. When available, links to guidances, MAPPs, and other resources, such as explanatory presentations, are included below.

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