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“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
The FDA issued 54 product-specific draft guidances Thursday that offer recommendations for developing 15 generic versions of drugs it says need competition. Read More
The FDA issued guidance Wednesday recommending technical specifications and general considerations on how certain comparative clinical endpoint bioequivalence study data and skin adhesion and irritation/sensitization study data for ANDAs should be submitted using FDA-supported data standards. Read More