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GUIDANCE DOCUMENT

Development of a Shared System REMS Guidance for Industry May 2018

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Development of a Shared System REMS Guidance for Industry

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

This guidance provides recommendations to industry on the development of a shared system risk evaluation and mitigation strategy (REMS)2 16 for multiple prescription drug (including biological) products. This guidance describes some of the possible benefits of a shared system REMS, and provides general principles and recommendations to assist industry with the development of these programs. This guidance does not discuss the process for requesting a waiver of the single, shared system REMS requirement that applies to abbreviated new drug applications (ANDAs) referencing a listed drug with an approved REMS. FDA issued a separate guidance describing the process for requesting waivers and the criteria FDA applies in considering them.


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.