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In this section: Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry November 2017

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:: FDA-2017-D-6231
Issued by:: Guidance Issuing Office

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

Guidance for Industry

Submit Comments

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-2017-D-6231.

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