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  • 1.  Cimzia Approval History

    Posted 30-Jan-2017 17:38
    Hello Everyone,

    I am writing an assignment on the approval history of the biologic CIMZIA for Rheumatoid Arthritis. Can anyone describe the reasons the company did not get first-time approval by FDA. Also, what did the company do in order to gain approval. 

    Any relevant sources or articles will also do. Thank you.



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    Sincerely,
    Harsh Raja,
    Candidate for Master's in Regulatory Affairs
    Northeastern University
    hkr21raja@gmail.com
    +1(857)-928-6284
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  • 2.  RE: Cimzia Approval History

    Posted 31-Jan-2017 08:57

    Anything you write for a class should be based on information that is publicly disclosed.

     

    Take a look at the history of Cimzia approvals (approval letters) posted at Drugs@FDA website; I don't believe that the efficacy review supporting this indication is available. You can glean clinical trial information from the updated labeling. There is also quite a bit of information that has been publicly disclosed – try a google search. And don't forget the company's website for press releases and clinical trial registries such as CT.gov.

     

    Linda Bowen

    Adjunct Professor

    Temple University RAQA Masters Program




    Original Message


  • 3.  RE: Cimzia Approval History

    Posted 31-Jan-2017 09:48
    You will generally find that type of information in advisory committee materials and transcripts rather than in the approval package materials.  I suggest searching "cimza fda advisory committee" and would be there may be useful info to find.

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    Debbie Koeneman
    Consultant
    Mesa AZ
    United States
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    Original Message


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