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  • 1.  Untitled Letter (FDA)

    This message was posted by a user wishing to remain anonymous
    Posted 01-Nov-2023 09:03
    This message was posted by a user wishing to remain anonymous

    How long after I've sent a response letter to an untitled letter should I expect to receive some sort of reply?



  • 2.  RE: Untitled Letter (FDA)

    Posted 02-Nov-2023 05:29

    Hello Anon,

    In short, it depends.  Depends on the situation, content of the letter, criticality of the issue, next steps, etc.  Even some times you might not get a response.  Since you say Untitled Letter, assuming you are speaking about US FDA, they have no obligation to send a confirmation or any other type of acknowledgement based on your response.  You might get an unscheduled inspection, you might get a thank you for information letter, and sometimes nothing.  The US FDA are getting better at replying to response letters in certain circumstances, but again it really depends on the content of the Untitled Letter and what it is about.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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