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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Not for implementation.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.

Docket Number:
FDA-2018-D-4629
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

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-4629.