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GUIDANCE DOCUMENT

Development of a Shared System REMS Guidance for Industry June 2018

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2018-D-1041
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.

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Submit Comments Online

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-1041.

 
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