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GUIDANCE DOCUMENT

Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications September 2018

Draft

Not for implementation. Contains non-binding recommendations.

Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This document provides guidance to industry and FDA staff on the contents of and submission procedures for threshold analyses and human factors (HF) submissions that will support efficient Agency review, and presents timelines for FDA’s review of such submissions.


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.