Survey Methodologies to Assess REMS Goals That Relate to Knowledge February 2019
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter 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.
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:
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.