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  • FDA Data Mining Project Proposal Once Again Withdrawn

    Earlier this week, Focus reported that a data mining project once abandoned by the US Food and Drug Administration (FDA) for lack of funding had been resurrected by the agency. Now, just days after the agency announced the project's return, it is once again cancelling the project-for now. Background FDA's data mining proposal has been in the works for more than a year. In April 2013, the agency established a notice indicating that it wanted to work with an outside com...
  • FDA Resurrects Data Mining Project Once Left for Dead

    The US Food and Drug Administration (FDA) has resurrected a once-canceled project intended to better mine data about adverse drug reactions from literature reports. Background FDA regularly puts out requests for proposals and solicitations on the Federal Business Opportunities (FBO) website, and has regularly expressed a keen interest in methods of monitoring adverse event data. In April 2013, for example, it put out a notice indicating it wants a partner to help it bu...
  • Revised FDA Manual Provides Statistical Reviewers with Standardized Template

    A revised Manual of Policies and Procedures (MAPP) developed for US Food and Drug Administration (FDA) drug review staff instructs them on how to assess statistical reviews using good review practices (GRPs) using a standardized review template. The MAPP, Good Review Practice: Statistical Review Template , specifically applies to employees within the Center for Drug Evaluation and Research's (CDER) Office of Translational Sciences (OTS)-an office charged with promot...