FDA’s Post-Market Pharmacoepidemiologic Study Guidance Is 3 Years Away
FDA told participants at a May 7 workshop that it plans to have draft guidance for conducting post-market pharmacoepidemiologic safety studies ready for review in fiscal 2010, with final guidance to be released a year later
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Guidance advises investigators how to work around limitations of electronic healthcare data; agency does not advocate specific type of study design but notes advantages of new (incident) user design.
Deal with WebMD enables FDA to reach more consumers though online polling techniques; the agency will also provide videos to the consumer Web site.
Proponents of the universal adoption of electronic health records might look to follow the "carrot and stick" incentives for electronic prescribing created by the new Medicare Improvements Act, Congressional Budget Office Director Peter Orszag suggests