Business · 29/10/2019
FDA Releases Draft Guidance for Industry on Type V Drug Master Files for CDER-Led Combination Products
The FDA has announced the availability of a draft guidance for industry on Type V Drug Master Files for CDER-led combination products featuring device constituent parts with electronics or software, outlining the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 →