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GUIDANCE DOCUMENT

Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry October 2017

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2017-D-6530
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance describes an enhanced pathway for discussions between FDA and a prospective 17 applicant preparing to submit or an applicant that has submitted an abbreviated new drug 18 application (ANDA) for a complex product to FDA as defined in this guidance. Specifically, 19 this guidance provides information on requesting and conducting product development meetings, 20 pre-submission meetings, and mid-review-cycle meetings with FDA.


Submit Comments

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

If unable to submit comments online, please mail written comments to:

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-6530.