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

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