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 enhancements, including the timelines for responding to controlled correspondence.

The following presentations explain important elements in GDUFA III regarding controlled correspondence. Where available, links to guidances, MAPPs, and other resources are contained below. Note: additional information and presentations will be added to this page on an ongoing basis as more guidances and MAPPs become available.

Controlled Correspondence Types and Timelines

The GDUFA III commitment letter includes definition updates, revised timelines, and program enhancements for the controlled correspondence process for ANDAs. As related guidances, MAPPs, and presentations are published, we will add them here.

• GDUFA III: Controlled Correspondence (recorded presentation)—Highlights from the Commitment Letter changes in GDUFA III (compared to GDUFA II) as it relates to Controlled Correspondence