Published in Law and Health Weekly, May 16th, 2009
Acorda received a Refuse to File (RTF) letter for the Fampridine-SR NDA on March 30, 2009, which cited the need to correct “format issues” and requested additional supporting information before the NDA could be accepted for review. Based on subsequent discussions with the FDA, Acorda has resubmitted the Fampridine-SR NDA and believes that all of the Agency’s comments related to the RTF have...
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