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GUIDANCE DOCUMENT

ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions December 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

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The Food and Drug Administration (FDA) is issuing this revised draft guidance to incorporate program enhancements related to the content, timing, and assessment of a pre-submission facility correspondence (PFC)2 within the abbreviated new drug application (ANDA) assessment program3 agreed upon by the Agency and industry as part of the reauthorization of the Generic Drug User Fee Amendments (GDUFA III), as described in GDUFA Reauthorization Performance Goals and Program Enhancements, Fiscal Years 2023 through 2027 (GDUFA III commitment letter).4 This guidance replaces the November 2017 draft guidance for industry on ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence).5

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

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