The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of a Drug Master File for Shared System REMS Submissions.'' The draft guidance provides information to applicants who are part of a shared system Risk Evaluation and Mitigation Strategy (REMS) on using an electronic Type V Drug Master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.
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Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategy Submissions; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of a Drug Master File for Shared System REMS Subm...
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82 FR 52058
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“Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategy Submissions; Draft Guidance for Industry; Availability,” thefederalregister.org (November 9, 2017), https://thefederalregister.org/documents/2017-24353/use-of-a-drug-master-file-for-shared-system-risk-evaluation-and-mitigation-strategy-submissions-draft-guidance-for-indus.