[LAW-LIB:58734] Clarification - New Drug Applications? Where to Find?

From: Wiest, Shauna L. (SLWIEST@stoel.com)
Date: Fri Apr 10 2009 - 09:11:28 PDT

  • Next message: Joe Hodnicki: "[LAW-LIB:58735] Friday Fun"

    Hello,

     

    For clarification, I am looking for the completed NDA submitted by the
    drug company. I do not need blank forms. Thank you!

     

    From: Wiest, Shauna L.
    Sent: Friday, April 10, 2009 10:00 AM
    To: law-lib@ucdavis.edu
    Subject: New Drug Applications? Where to Find?

     

    Hello,

     

    I have an urgent request from a lawyer. I am looking for a New Drug
    Application (NDA). I have all of the information for the NDA (Title,
    Date, Docket), but cannot locate a copy on the CDER website or from
    another source. I have left a message with the FDA (CDER) for more
    information.

     

    I am thinking the NDA's are confidential, and are not available to the
    public, accept perhaps, via a FOIA request. If someone is familiar with
    the process of obtaining an NDA, I would sure appreciate an email or a
    phone call.

     

    Thanks so much!

     

    Shauna L. Wiest | Office Librarian

    STOEL RIVES LLP | 201 S. Main St, Suite 1100 | Salt Lake City, UT
    84111-4904

    Direct: (801) 715-6645 | Fax: (801) 578-6999

    slwiest@stoel.com | www.stoel.com

     

    This email may contain material that is confidential, privileged and/or
    attorney work product for the sole use of the intended recipient. Any
    unauthorized review, use, or distribution is prohibited and may be
    unlawful.

     

    This archive was generated by hypermail 2b29 : Fri Apr 10 2009 - 09:12:40 PDT