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GUIDANCE DOCUMENT

Classifying Significant Posmarketing Drug Safety Issues March 2012

Draft

Not for implementation. Contains non-binding recommendations.

Classifying Significant Posmarketing Drug Safety Issues

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

This guidance describes the framework the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) intends to use in classifying significant postmarketing drug2 safety issues as priority, standard, or emergency. Significant postmarketing safety issues include serious adverse events, product quality issues, and medication errors. This classification framework will enable CDER to direct its resources toward the safety issues that pose the greatest potential risk for patients. CDER invites public comment on the factors to be used and the methodological approach.


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.