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US FDA And NIST Form Partnership To Boost Advanced Manufacturing Techniques

Executive Summary

The US FDA and NIST have agreed to help industry modernize and update pharmaceutical manufacturing methods and to improve supply chain resilience.

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Need For Advanced Manufacturing Technologies A ‘Great Learning’ From The Pandemic, CBER’s Marks Says

COVID-19 highlighted limited domestic capacity and need for more flexibility, agility and reliability in manufacturing processes, says FDA biologics center director Peter Marks; he also discussed differences in data review for vaccine BLAs relative to EUAs.

Advanced Manufacturing May Require US FDA To Think Differently About Guidance

National Academies report argues that technologies cannot only be evaluated in the context of specific products, and FDA guidance should become both ‘more fluid and targeted.’

Advanced Manufacturing May Require US FDA To Think Differently About Guidance

National Academies report argues that technologies cannot only be evaluated in the context of specific products, and FDA guidance should become both ‘more fluid and targeted.’

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