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  • 1.  Day 120 safety report for NDA

    Posted 08-Nov-2015 09:11

    Hi colleagues,

    I would appreciate your help to confirm that the start date for the Day 120 safety report for an NDA is the date of the submission of the NDA. I can find no other information beyond what is cited in the CFR.  Thanks for your help.

     

    Elizabeth Ashraf, Ph.D.

    PTC Therapeutics







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  • 2.  RE: Day 120 safety report for NDA

    Posted 08-Nov-2015 20:37
    Liz,

    Please refer to 21 CFR 314.50(d)(5)(vi)(b)) or 21 CFR 314 in PDF here. 
     
    Thank you.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


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

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  • 3.  RE: Day 120 safety report for NDA

    Posted 10-Nov-2015 11:07

    Hi Liz,

    Please also note in the regulations identified by David that following; "Prior to the submission of the first such report, applicants are encouraged to consult with FDA regarding further details on the form and content".  The strategy and proposal for a 120-day safety update should be part of your pre-submisison meeting with FDA.  One needs to be careful about this submission as it could impact the review clock (priority review is 6 months) in significant and FDA cannot then meeting the PDUFA goal.  

    Also remember that the initial submission will be after the 60 day validation period.

    All the best,

    Dar

    ------------------------------
    Darlene Rosario MBA, RAC
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States

    Original Message