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WASHINGTON — Federal regulators have issued a warning to GlaxoSmithKline for not reporting safety results on its diabetes pill Avandia, which received a prominent warning label last year.
The Food and Drug Administration said that between 2001 and 2007 the drugmaker did not annually update the agency on more than 10 ongoing studies of Avandia, as required by regulations.
While the agency acknowledges information from the studies was disclosed in other notices, the omissions “are serious and may be symptomatic of underlying post-market reporting failures.”
