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GUIDANCE DOCUMENT

Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategy Submissions November 2017

Final

This guidance is being distributed for comment purposes only.

Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategy Submissions

Docket Number:
FDA-2017-D-6231
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of a Drug Master File for Shared System REMS Submissions.” The draft guidance provides information to applicants who are part of a shared system Risk Evaluation and Mitigation Strategy (REMS) on using an electronic Type V Drug Master File (DMF). FDA recommends that applicants who are part of a shared system REMS use a Type V DMF for their REMS submissions to improve the efficiency of the submission and review process.


Submit Comments

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:

Division of Dockets Management (HFA- 305)
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.