Business · 07/01/2004Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information
Summary
The Food and Drug Administration (FDA) has made available a draft guidance document outlining recommendations for the chemistry, manufacturing, and controls (CMC) information required for drug substances to support new drug applications, including original NDAs and ANDAs.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →