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Feinstein announces submission of new drug application for diagnosing parkinsonian syndromes
Date:11/14/2012
ership of David Eidelberg, MD, Thomas Chaly, PhD, and Vijay Dhawan, PhD. It is under the leadership of Dr. Chaly that the Feinstein Institute achieved the FDA approval of the Expanded Access IND with payment and the submission of a NDA for Fluorodopa F 18 Injection. The Feinstein Institute is the first and only research institute to receive approval from the FDA to use FDOPA PET scan under an Expanded Access IND program, allowing Feinstein Institute researchers and doctors to use the diagnostic tool in clinical research studies and receive reimbursement.
"We submitted a full New Drug Application for FDOPA PET scan, as we believe this will provide national recognition for an important diagnostic," said Dr. Chaly. "The FDOPA PET scan, if approved, has the potential to improve the quality of life for patients with parkinsonian symptoms by thwarting unnecessary costs and side effects from treatments."
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| Contact: Emily Ng eng3@nshs.edu 516-562-2670 North Shore-Long Island Jewish (LIJ) Health System Source:Eurekalert |
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