Business · 31/01/2005Updated: 10/17/2026 · 1 min read

FDA Releases Draft Guidance on Impurities in Drug Substances for Industry

The Food and Drug Administration (FDA) has made available a draft guidance document outlining recommendations for reporting impurities in drug substances produced through chemical synthesis, in support of abbreviated new drug applications (ANDAs), drug master files (DMFs), or supplements to existing applications.