Regulatory Open Forum

 View Only

  • 1.  IND Safety Reporting

    Posted 12-Feb-2016 14:59

    Hello,

    I have a quesiton related to reporting of IND safety reports and what is being done in industry.  If a sponsor is using the same compartor drug across multiple INDs would the sponsor need to report the comparator safety reports to all INDs they are using it agains or only the IND that the report was generated from.

    Thanks in advance for your input. 

    ------------------------------
    Kathy SchmutzUnited States
    ------------------------------


  • 2.  RE: IND Safety Reporting

    Posted 13-Feb-2016 19:14
    Kathy,

    There are two prevailing FDA guidances in relation to your question.  Simply speaking, you may make a reference to in lieu of reporting to multiple INDs.  

    IND safety reporting for human drugs and biological products developed under an IND.

    IND safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies.

    To better meet the IND safety reporting requirements, sponsors are recommended to periodically review "accumulating safety data collected across multiple studies (completed and ongoing)" and other sources...."  

    As for safety reporting, you would want to ensure that a systematic approach and quality of safety reporting are implemented. 

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 3.  RE: IND Safety Reporting

    Posted 14-Feb-2016 12:25

    The adverse event needs to be reported to all INDs that use that drug product.

    It's called cross-reporting. 

    ------------------------------
    Shannon Wehrendt MA
    Senior Associate, Regulatory/Quality


    Original Message


  • 4.  RE: IND Safety Reporting

    Posted 15-Feb-2016 13:42

    In addition, if the comparator is a marketed generic product, you'll need to report to the innovator.  Take a look at the recent FDA guidance related to safety reporting to IND, as it may provide you additional information: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm477584.pdf

    Fda remove preview
     
     
     
    View this on Fda >

    Kind regards - 

    ------------------------------
    Janet Rose Rea, MSPH
    Shoreline WA
    United States

    Original Message