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  • 1.  PDUFA User Fee Waiver

    Posted 08-Jan-2016 08:39

    Regarding small business user fee waiver application, I have followed the guidance and submitted supportive documentation within the requested time period.  Now waiting for a response.  I have been not be able to successfully contact the agency via telephone or get a response from the email helpdesk --  my time is running short.   Seeking any guidance additional recourse.   

     

    Evelyn Jaeger

     

    Tel: 212-584-7605 office

    Tel: 646-675-7283 mobile

    Fax: 646-961-4787

    ejaeger@synergypharma.com

     

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  • 2.  RE: PDUFA User Fee Waiver

    Posted 10-Jan-2016 11:21

    Hi Evelyn

     

    Try contacting Beverly Friedman (301-796-7900) or Katherine (Katie) Stronati in the User Fee office.  They've been very helpful to me in the past regarding waivers and refund requests.  If they can't answer your question – hopefully they can point you in the right direction on who to talk to.  Katie may have recently move doubt of the User Fee office so I suggest starting with Beverly.  Good luck.

     

    Tom

     




    Original Message


  • 3.  RE: PDUFA User Fee Waiver

    Posted 11-Jan-2016 07:28

    Evelyn,

    But has FDA sent you a letter regarding requirements that need to be sent to the small business Administration? Have you called Beverly Friedman, User Fee Waiver Staff at FDA? If not, she is who I would start with. It actually took my company about 6 months for us to get our waiver.  

    ------------------------------
    John Lay
    Director, Regulatory and Quality
    Vistapharm Inc.
    Largo FL
    United States

    Original Message