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2023 US FDA Drug Quality Guidance Expected To Include 20-Year CTD Update, Much More

 
• By Bowman Cox

A revision of the ICH Common Technical Document expected this year will set the global stage for eventual “structured” quality submissions. Meanwhile, the FDA plans to complete work on ICH impurities guidance and advanced manufacturing technology guidance.

FDA pointing the way
The FDA points the way to expected guidance. • Source: Shutterstock

A major update of the format for quality submissions headlines the US Food and Drug Administration’s Center for Drug Evaluation and Research agenda for new and revised drug quality guidance in 2023.

The list includes an FDA-proposed revision of the September 2002 International Council on Harmonisation guidance on the quality aspects of the Common Technical Document for drug applications

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