Manufacturing Updates in Brief
This article was originally published in The Gold Sheet
GMP issues delayed Boehringer launch; Nigerian firms meet WHO GMPs; Novartis closing Puerto Rico plant; Hospira closing Clayton site; Valeant looks to move Bausch + Lomb manufacturing abroad; these IV bags were training aides.
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Sponsor’s claimed impact on exercise tolerance was not adequately supported and should not serve as a marketing advantage for the chronic obstructive pulmonary disease drug, FDA review staff said. However, Boehringer Ingelheim’s failed attempt for the exercise-related labeling language spurred the agency to clarify the types of studies and endpoints that potentially could support such claims.
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