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GUIDANCE DOCUMENT

Safety Assessment for IND Safety Reporting Guidance for Industry December 2015

Draft

Not for implementation. Contains non-binding recommendations.

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

This document provides guidance to sponsors on developing a systematic approach for investigational new drug application (IND) safety reporting for human drugs and biological products developed under an IND. See section II.A of this guidance for an overview of the IND safety reporting requirements. This guidance is a follow-on to the guidance for industry and investigators Safety Reporting Requirements for INDs and BA/BE Studies and provides recommendations for how sponsors of INDs can identify and evaluate important safety information that must be submitted to FDA and all participating investigators under the IND safety reporting regulations at § 312.32 (21 CFR 312.32). This guidance is most applicable to sponsors managing a drug development program that has multiple studies. This guidance contains recommendations on the following: (1) the composition and role of a safety assessment committee, (2) aggregate analyses for comparison of adverse event rates across treatment groups, (3) planned unblinding of safety data, (4) reporting thresholds for IND safety reporting, and (5) the development of a safety surveillance plan.


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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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