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RECENT SHARED FILES

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RECENT BLOGS

  • David Lim

    FDA Guidance: Analytical Procedures and Methods Validation for Drugs and Biologics

    Regulatory Open Forum

    Today (July 24, 2015), FDA issued an important guidance entitled " Analytical Procedures and Methods Validation for Drugs...

  • Karin Hjorth

    Regulatory Has a Seat at the Table - Now What?

    We’ve been saying we need a seat at the table. And now we finally have one. So what next? As Regulatory partners...

    4 people recommend this.
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    Request for HUD Designation (HDE Application)

    Does someone out there have proven templates for a HDE Designation application and a application for HUD. Thanks in advance...

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