ANDAs: Pre-Submission Facility Correspondence Related to Prioritized G

Docket Number: FDA-2017-D-3101 Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research, Office of Pharmaceutical Quality

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “ANDAs:  Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions.” This guidance describes the facility information to be submitted in a pre-submission facility correspondence (PFC) and how FDA will use this information to set a review goal for a priority abbreviated new drug application (ANDA). This guidance incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA) and as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (GDUFA III commitment letter). This guidance finalizes for implementation the draft guidance of the same title issued on December 5, 2022.

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All written comments should be identified with this document’s docket number: FDA-2017-D-3101.

• Content current as of:

  06/13/2025

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