Business · 06/10/2022Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance on Review of Drug Master Files Ahead of Generic Drug Submissions
Summary
The FDA is announcing the availability of a draft guidance for industry on reviewing drug master files in advance of certain abbreviated new drug application submissions under the Generic Drug User Fee Amendments program.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →