A Doggone Shame for Vanda: DC District Court Grants FDA’s Remand Motion on Dog Study/IND Clinical Hold Challenge

By Sara W. Koblitz — About 6 weeks after Vanda filed its complaint, the company’s lawsuit has joined its clinical trial: on hold.  Last week, the District Court of D.C. granted FDA’s motion for a voluntary remand of the case challenging FDA’s requirement to perform 9-month large animal studies prior to commencing studies in humans staying the case for 45 days from the Court’s Order while FDA reevaluates its position.  While Vanda supported a voluntary remand, it strongly advocated that the Court stay the case while vacating the clinical hold on its 52-week human study. FDA requested a voluntary remand to “address certain procedural issues Vanda noted in its Complaint, including the allegations about the agency’s response to scientific arguments submitted by Vanda and the treatment of a guidance document as a binding rule.”  Notwithstanding all the usual pre-litigation negotiations about the issue that were discussed…

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