Exubera’s Post-Marketing Safety Program Is Industry Model – Pfizer’s Ryder
Pfizer's proposed post-marketing studies for the inhaled insulin therapy Exubera exemplify the type of risk management programs FDA should encourage industry to conduct, Pfizer Clinical R&D Senior VP Steven Ryder told an Institute of Medicine committee on Jan. 19
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Marketing of Pfizer's inhaled insulin Exubera for treatment of adult diabetes mellitus is expected to begin by the end of August
Drug manufacturers need more clarity from FDA regarding post-marketing studies, industry representatives told the Institute of Medicine's Committee on the Assessment of the U.S. Drug Safety System