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Guidance Issuing OfficeCenter 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of a Drug Master File for Shared System REMS Submissions.” The draft guidance provides information to applicants who are part of a shared system Risk Evaluation and Mitigation Strategy (REMS) on using an electronic Type V Drug Master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.
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:
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.