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FDA Issues Complete Response Letter to Ipsen for Dysport Biologics


FDA Issues Complete Response Letter to Ipsen for Dysport Biologics License Application (Business Wire via Yahoo! Finance)
PARIS----Regulatory News: No additional clinical data requested Manufacturing process for Dysport in compliance with CGMPs1No Form 483 observation listed FDA requests finalization of the Risk Evaluation and Mitigation Strategy and labelling Stepping-up to Dysport s full launch preparation phase
 

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