FDA believes that comparative pharmacokinetic studies, instead of comparative clinical endpoint studies, are best for determining bioequivalence of extended- or delayed-release mesalamine products - a reversal of its previous position
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Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
