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  • 1.  Seeking comments on US FDA's Ombudsman in CDER and CDRH

    Posted 19-Jun-2017 08:53
    Hello:

    I am seeking your comments on recent experience (2015 - present) in working with FDA's ombudsman at FDA/CDER and/or FDA/CDRH.

    In particular, how was your issue handled and resolved including timeline?

    You may send me your comments through RAPS' email or my Gmail at regulatorydoctor@gmail.com

    Thank you for sharing your experience in advance. 

    Thank you.

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

    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.




  • 2.  RE: Seeking comments on US FDA's Ombudsman in CDER and CDRH

    Posted 20-Jun-2017 08:52
    Hi David,

    I had the unfortunate need to contact the CDRH ombudsman in the last couple of years. It was related to a delayed review of a de novo device.  I had a response from the ombudsman the same day and a phone call from Center Director's office within 2 days after that.  I started receiving review comments the next week.

    ------------------------------
    Glen Park
    Scynexis, Inc.
    Jersey City NJ
    United States
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    Original Message


  • 3.  RE: Seeking comments on US FDA's Ombudsman in CDER and CDRH

    Posted 20-Jun-2017 09:49
    Glen,

    Thank you for sharing your practical experience.  Good to hear your positive, prompt procedural experience with the CDRH ombudsman. I know it would depend on the complexity of the matter.  

    We industry would like to see such speedy process.  

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

    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


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