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  • 1.  CMC Training Recommendations

    This message was posted by a user wishing to remain anonymous
    Posted 26-Oct-2022 14:48
    This message was posted by a user wishing to remain anonymous

    Hello!  I am looking for recommendations for CMC training for (A)NDAs.  More specifically around how to assessment post-approval changes which impact currently marketed drug products in accordance with FDAs guidance documents to determine if they are AR, CBE-0, CBE-30, or PAS.  Any recommendations that you may have would be greatly appreciated!


  • 2.  RE: CMC Training Recommendations

    Posted 26-Oct-2022 18:37
    Dear Anonymous,

    As a start I would suggest you look into The Center for Professional Advancement (CfPA), Pharmawebinars.com, and ISPE International.  You could also consider hiring a consultant that has expertise in CMC to conduct internal training on this topic especially if you have specific examples.  Lastly, there are examples in the FDA guidance on Post Approval Changes to be submitted in ARs for that are useful. 

    Hope this is somewhat helpful,

    Dar

    ------------------------------
    Darlene Rosario MBA, RAC
    Principle Consultant
    Ventura CA
    United States
    ------------------------------

    Original Message


  • 3.  RE: CMC Training Recommendations

    This message was posted by a user wishing to remain anonymous
    Posted 28-Oct-2022 10:29
    This message was posted by a user wishing to remain anonymous

    While not a substitute for training, here's a great blog post about the new guidance on Comparability Protocols, which is a significant part of learning post-approval CMC Regulatory: https://www.thefdalawblog.com/2022/10/fda-adds-additional-qas-in-the-final-cmc-postapproval-changes-guidance/
    Original Message


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