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GUIDANCE DOCUMENT

Survey Methodologies to Assess REMS Goals That Relate to Knowledge January 2019

Draft

Not for implementation. Contains non-binding recommendations.

Survey Methodologies to Assess REMS Goals That Relate to Knowledge

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

This guidance provides recommendations to industry on conducting risk evaluation and 17 mitigation strategies (REMS) assessment surveys, used to evaluate respondent knowledge of 18 REMS-related information. This guidance discusses general principles and recommendations 19 related to conducting REMS assessment knowledge surveys, including study design, survey 20 instrument development, survey data collection and processing, and data analysis.


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.