Business · 21/02/2017Updated: 10/17/2026 · 1 min read
FDA Publishes Draft Guidance on Starting Materials for Drug Substances
Summary
The FDA has released a draft guidance document, Q11, which provides answers to questions about selecting and justifying starting materials for drug substances, in collaboration with the International Council for Harmonisation (ICH).
Original source language: Federal Register — Food and Drug AdministrationOpen original release →