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GUIDANCE DOCUMENT

Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry Guidance for Industry September 2023

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2018-N-3771
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments:  Using Forms FDA 3988 and FDA 3989.”  Forms FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, and FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics, are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on postmarketing requirements (PMRs) and postmarketing commitments (PMCs) in a consistent format.  These forms are expected to result in improved accuracy and timeliness of FDA’s identification and review of those submissions containing information on PMRs and PMCs.  This guidance covers the purpose of each form, when to use these forms, and how to submit these forms.  The guidance also explains where applicants will be able to find the forms and instructions.  This guidance finalizes the draft guidance of the same name issued on October 21, 2020.

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All written comments should be identified with this document's docket number: FDA-2018-N-3771.

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