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Quality by Design: Next Steps to Realize Opportunities? - page 32 / 37

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What steps (is) should FDA (taking) take to realize the benefits of QbD?

Start to build elements of “Pharmaceutical Development” in all relevant guidance documents (e.g., Draft Drug Product Guidance)

Support development of ICH guideline on “Pharmaceutical Development”

Train FDA staff on how to evaluate the knowledge content of “Pharmaceutical Development Reports”

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