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  • 1.  GDUFA and PDUFA Fees for Contract Sterilizers

    Posted 12-Dec-2013 16:29
    Dear Peers,
    Would you please provide your expert opinion related to below listed questions:

    1. Are GDUFA and PDUFA facility registration fees required for contract sterilizers?
    2. How facility appears under the GDUFA/PDUFA arrears list?

    Thank you in advance. 

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    Marinela Cebic
    Tampa FL
    United States
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  • 2.  RE:GDUFA and PDUFA Fees for Contract Sterilizers

    Posted 13-Dec-2013 09:45
    If the contract sterilizer is for packaging components only, the fees do not apply.  If they sterilize the drug product, the fees apply.  FDA publishes an arrears list with all the outstanding company names on it. 

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    Janet DeLeon RAC
    CEO
    DeLeon Pharmaceutical Consulting, LLC
    Leawood KS
    United States
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    Original Message


  • 3.  RE:GDUFA and PDUFA Fees for Contract Sterilizers

    Posted 13-Dec-2013 10:00
    This link should solve your query 2:
    http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm319572.htm


    Hope this Helps
    Regards
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    Dakshesh Patel
    Syracuse NY
    United States
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    Original Message