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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Not for implementation.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.

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

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

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.