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GUIDANCE DOCUMENT

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

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2018-D-3275
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.

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Submit Comments Online

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-2018-D-3275.

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