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NOTICE:

FDA audit - notice of compliance

An important mission of the Center for Movement Disorder Surgery is to carry out medical research and advance the state-of-the-art in this field. All of our work adheres to the highest standards of ethics and professionalism.

In 2003, a research study conducted at the Center for Movement Disorder Surgery between 1999 and 2002 was randomly audited by the FDA as part of routine surveillance. After three years of investigations,March 20, 2008of inspection describing full compliance, and no further need for response [May 5, 2006].

The study, a blinded, randomized trial of subthalamic nucleus stimulation in patients with advanced Parkinson's disease, was published in 2004, and widely praised in the medical field for its design, integrity and accuracy of its conclusions.

view Subthalamic nucleus stimulation study
view FDA letter


Selected publications

  • Ford B, Winfield L, Frucht PE, Cheringal J, Du E, Pullman S, Yu Q, Fahn S, Cote LJ, McKhann GM, Goodman RG. Subthalamic nucleus stimulation in Parkinson's disease: blinded evaluations at one year follow-up (submitted).

  • Ford B. Pallidotomy for generalized dystonia. Adv Neurol 2003 (in press).

  • Surgery for Parkinson’s Disease: A guide for patients, families and caregivers. Parkinson’s Disease Foundation, 2003.

  • Fahn S, Ford B. Medical treatment of Parkinson's disease and its complications. In: J Noseworthy, ed. Neurological Therapeutics: Principles and Practice. London: Martin Dunitz, 2003.

  • Ford B. Deep-brain stimulation in Parkinson's disease. N Eng J Med 2002;346:452-3 [letter].

  • Ford B. Intrathecal Baclofen for Dystonia. In: D Tarsy, J Vitek and A Lozano, eds. Surgical Treatment of Movement Disorders. Totowa, NJ: Humana Press, 2002.

  • Ford B, Fahn S. Agents for Treating Parkinson's Disease and Other Movement Disorders. In: LP Rowland, ed. Current Neurologic Drugs, 3rd edition. Philadelphia: Current Medicine, 2000.

  • Ford B, Greene P, Louis ED, Petzinger G, Bressman SB, Goodman R, Brin MF, Sadiq S, Fahn S. Use of intrathecal baclofen in dystonia. Arch Neurol 1996;53:1241-1246.
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Center for Movement Disorders Surgery • 710 W 168th St, New York, NY 10032
Updated March 20, 2008
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