Northera Review Shows Regulatory Challenges In Difficult Therapeutic Space
Chelsea Therapeutics’ development program for droxidopa in neurogenic orthostatic hypotension led to discussion at a recent advisory committee meeting about the role of Special Protocol Assessments and appropriate validation of patient-reported outcome instruments.
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The Cardiovascular and Renal Drugs Advisory Committee Jan. 14 supported approval of the drug for symptomatic neurogenic orthostatic hypotension on a vote of 16-1.
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