Published in FDA Law Weekly, August 12th, 2004
The fast track program is designed by FDA to facilitate the development and expedite the review of drug candidates that demonstrate the potential to treat serious or life-threatening diseases and address unmet medical needs. Spheramine is a cell therapy product initially being developed for the treatment of advanced Parkinson patients who are not satisfactorily controlled with current medications.
Spheramine consists of normal, human retinal pigment epithelial...
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