Regulatory Open Forum

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  • 1.  Labeling Change

    Posted 30-Sep-2014 10:25
    Hello,

    We are planning to revise our labeling to add "DO NOT FREEZE" on the label. but this sentance is not listed on RLD labeling.

    What is the procedure to revise the labeling? what submission will support this change? CBE0, CBE30 or PAS?

    any reference guidance supporting the submission?

    please advise ASAP.

    Thx

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    Chetan Khamar
    Piscataway NJ
    United States
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  • 2.  RE: Labeling Change

    Posted 01-Oct-2014 12:09
      |   view attached

    FDA has a RLD revision guidance on their website at www.fda.gov.
    -------------------------------------------
    Melissa Traylor
    Manager, Regulatory Affairs
    FzioMed, Inc.
    San Luis Obispo CA
    United States
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    Attachment(s)

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    3703fnl (2).pdf   14 KB 1 version
    Original Message


  • 3.  RE: Labeling Change

    Posted 01-Oct-2014 13:05
    What kind of ANDA (general ANDAs or OTC ANDAs)?

    Please refer to FDA guidances at http://www.fdaguidance.net/changes-to-an-approved-nda-or-anda/

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    Original Message


  • 4.  RE: Labeling Change

    Posted 02-Oct-2014 08:30

    It is for our ANDA.

    On Nov. 13, 2013, the Food and Drug Administration (FDA) published a Proposed Rule in the Federal Register. The title of the Proposed Rule is "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products."

    and i have heard FDA accepting labeling changes if its different than RLD. do you have any experience/input on this proposed rule?

    i have read many different guidance document but none is clear on how should i submit this change?


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    Chetan Khamar
    Piscataway NJ
    United States
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    Original Message


  • 5.  RE: Labeling Change

    Posted 01-Oct-2014 16:30
    Chetan, 

    Please reference the Guidance for Industry Label of Human Prescription Drugs and Biological  Products; Implementing the PLC Content and Format Requirements. Specifically,


    Since the ANDA is to have identical labeling to the RLD, I would suggest PAS and consultation with the reviewing Division.

    Hope this is helpful,

    Dar

    -------------------------------------------
    Darlene Rosario, B.S., MBA, RAC
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States
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    Original Message