Regulatory Open Forum

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  • 1.  Annual Report

    Posted 16-Oct-2014 08:48

    Dear Mr/Ms.

    Can someone kindly advise me where and which address do I my ANDA annual report to?
    Is it the document control (DCU) or OGD or Division of Drug Evaluation II?

    Best,

    Ed
    -------------------------------------------
    Ed Lin
    United Biomedical Inc
    Hauppauge NY
    United States
    -------------------------------------------


  • 2.  RE: Annual Report

    Posted 17-Oct-2014 09:40
    Hi Ed,

    It should go to OGD addressed to

    Kathleen Uhl, M.D., Acting Director
    Office of Generic Drugs
    Center for Drug Evaluation and Research
    Food and Drug Administration
    Metro Park North VII
    7620 Standish Place, Room 150
    Rockvill, MD 20855


    Original Message


  • 3.  RE: Annual Report

    Posted 18-Oct-2014 09:04
    Good morning, Zuriash.

    Thanks for your information about submission of my Annual Report for ANDA.

    One of our members suggested DCU and the others recommended Division Director.
    And, that is how I got confused. But, appreciate your very kind response. 

    Best,

    Ed Lin
    Quality & Regulatory
    United Biomedical Inc,
    New Yoork

    -------------------------------------------
    Ed Lin
    United Biomedical Inc
    Hauppauge NY
    United States
    -------------------------------------------


    Original Message


  • 4.  RE: Annual Report

    Posted 20-Oct-2014 18:56
    Yes, small typo Rockville with an "e".....

    Couldn't resist, ;-D

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


    Original Message


  • 5.  RE: Annual Report

    Posted 17-Oct-2014 11:41
    Hi Ed,

    In accordance with 21CFR314.81, the applicant shall submit the annual report to the FDA division responsible for reviewing the application. The cover letter should be to the head of the Division and I always CC, the project manager.

    Hope this is helpful,

    Dar

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


    Original Message


  • 6.  RE: Annual Report

    Posted 18-Oct-2014 09:09
    Good morning, Dar.

    Thank you for your information about submission of Annual Report of ANDA to
    Division head.

    One of our members suggested DCU and the other recommended OGD, and that is how
    I got confused. But, thank you for your kind response.

    Best,

    Ed Lin
    QA & Regulatory
    United Biomedical, Inc.
    New York

    -------------------------------------------
    Ed Lin
    United Biomedical Inc
    Hauppauge NY
    United States
    -------------------------------------------


    Original Message