Business · 29/10/2019Updated: 10/17/2026 · 1 min read

FDA Releases Draft Guidance for Industry on Type V Drug Master Files for CDER-Led Combination Products

Summary

The FDA has announced the availability of a draft guidance for industry on Type V Drug Master Files for CDER-led combination products featuring device constituent parts with electronics or software, outlining the administrative process and recommended content for these submissions.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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