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FDA Commish challenges drugmakers to boost quality

In speech to generics makers, Hamburg reminds them of lapses
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FDA Commissioner Margaret Hamburg recently complimented the work generic drugmakers have done on helping the agency face down shortages before laying into them about shortcomings. In a speech to the Generic Pharmaceutical Manufacturers Association posted on the FDA website, Hamburg said: "There are few American households who have not benefited from the success of the generic drug industry. Your task, and our task, is ensuring that the medications that these millions of Americans take every day are safe, effective and of high quality." Then she said there were "far too many quality lapses throughout the pharmaceutical industry over the past few years." In the lengthy speech, Hamburg went on to say that the agency will make quality a special focus this year and asked generic drugmakers to meet the highest standards to maintain their reputations. Read the speech | More