Business · 15/05/2014Updated: 10/17/2026 · 1 min read
FDA Releases Guidance on Stability Testing for ANDAs
Summary
The Food and Drug Administration (FDA) has published a guidance document clarifying stability testing recommendations for abbreviated new drug applications (ANDAs) and addressing public comments, replacing a previous draft guidance published in 2013.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →