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Sen. Claire McCaskill (D-Mo.) called on Nostrum Pharmaceuticals, a drugmaker with facilities in Kansas City, to explain a reported 400 percent price hike in its bladder infection treatment, nitrofurantoin. Read More
FDA Commissioner Scott Gottlieb Friday announced a four-pronged agency initiative to take on antimicrobial resistance, in part by creating incentives for drugs that treat it. Read More
One of the most effective ways for the FDA to increase patient access to high quality generics is to offer guidance that promotes the development of cost-saving generics, especially for complex drugs that are difficult to copy, he said. Read More
“Some language suggests that there is the possibility of patient experience data collected outside of pivotal trials to be included in labeling,” Allergan noted, requesting further details on the statistical significance and replication standards the agency expects to be met. Read More
The study, led by University of Oxford researcher Ben Goldacre, found that 32 major universities did not report results for any trials they sponsored. Read More
Despite EU requirements for clinical trials to report results to the EU Clinical Trials Register within a year of a trial’s completion, sponsors have only reported about half of them so far, BMJ reported Wednesday. Read More
In comments on the first of four FDA patient experience data guidances, Allergan and Roche urged the agency to add more details on data that can be used in labeling. Read More