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GUIDANCE DOCUMENT

Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry October 2022

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2017-D-5739
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated new drug application (ANDA) for a complex product, as defined in this guidance. Specifically, this guidance provides information on requesting and conducting product development meetings, pre-submission meetings, mid-cycle review meetings, enhanced mid-cycle review meetings, and post-complete response letter scientific meetings with FDA.

This guidance revises the guidance of the same title issued in November 2020. This revision is being issued to incorporate information on the complex product meeting types and performance goals included in the Generic Drug User Fee Amendments Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter), including information on requesting these meetings and FDA’s procedures for handling these meetings.

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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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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-5739.

 
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