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FDA Finalizes Guidance on Drug CMC Postapproval Changes and Allows More to Be Submitted in Annual Reports, Instead of Supplements

07 March 2014

Focus on Regulation

Over the years, the number of chemistry, manufacturing, and controls (CMC) postapproval drug manufacturing supplements for NDAs and ANDAs submitted to FDA has continued to increase.

Read More: FDA Finalizes Guidance on Drug CMC Postapproval Changes And Allows More To Be Submitted in Annual Reports, Instead of Supplements

The team

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