FDA Issues Important Guidance on CMC Post-Approval Manufacturing Changes to be Reported in Annual Reports

FDA has just issued their guidance document on post manufacturing changes for NDA and ANDAs to be documented in the annual report.  These are CMC changes that have minimal potential to have an adverse effect on product quality. There are 2 appendices that list the CMC changes determined to be of low risk to product quality.  These considerations are important to note, because as we know, supplements to the regulatory filing, take time and cost money.  We have seen many 483 observations from FDA regarding  post approval CMC changes.  This document is the result of FDA assessing the low risk of certain changes and compiling those changes for consideration by industry.

Read the guidance here.


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