FDA describes informatics' role in regulatory makeover; risk-benefit analysis a topic at statistics workshop;

> "Enhancing Safety and Health Through Informatics" is a chapter in the newly published Advancing Regulatory Science for Public Health, which describes the FDA's Regulatory Science Initiative. Article | Document download

> Risk-benefit analysis joined missing data, meta-analysis and adaptive design at the recent FDA/Industry statistics workshop. Column

> The best way to plan a study is to work backwards, starting with the statement you want to truthfully make about the product; a statistician's input will ensure process integrity. Column

> Last year's H1N1 pandemic proved challenging for disease surveillance systems; mobile messaging may make the job easier. Article

> The recent Avandia decision shows that drug market approval is no longer a black-and-white activity; expect the FDA to become data-hungry in upcoming approvals. Article

> The Virginia Bioinformatics Institute to model immune responses to gut pathogens. Release

> Subject-recruitment specialist Acurian has named Kim Basciani director for eRecruitment. Release

> Electronic patient-reported outcomes solution provider PHT Corp has named Elizabeth Ricci its VP for product development. Article