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Post Marketing studies- Observational Non-inteventional study

  • 1.  Post Marketing studies- Observational Non-inteventional study

    This message was posted by a user wishing to remain anonymous
    Posted 28-Nov-2018 10:22
    This message was posted by a user wishing to remain anonymous

    Hello,

    We work on a non-interventional observational registry for autoimmune disease and have some questions regarding post marketing studies.

    • Do the Phase IV Post Marketing study of approved drug or Phase IV trials receive 483s?
    • Do the FDA audit Post Authorization Safety Studies (PASS Protocols). What are the implications if an approved drug is found to be non-compliant in Post Market studies.

    Thank You for your help in advance.



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