This Risk Evaluation and Mitigation Strategy (REMS) Document Technical Conformance Guide (Guide) provides updated, detailed instructions on the format of a REMS Document, along with standardized language that describes common REMS requirements for applicants to use whenever possible, to help ensure consistency and facilitate efficient review of the REMS Document. This Guide supports submission of a REMS Document in Structured Product Labeling (SPL) format. In addition, this Guide provides an outline to assist applicants in drafting a Bifurcated REMS Document.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.