Business · 01/03/2023Updated: 10/17/2026 · 1 min read
FDA Releases Final Guidance on Continuous Manufacturing of Drug Substances and Products
Summary
The FDA has released a final guidance for the pharmaceutical industry on continuous manufacturing (CM) of drug substances and products, replacing previous drafts from 2019 and 2021. The guidance, developed by the ICH, clarifies CM concepts and provides scientific and regulatory considerations for its development and implementation.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →