CDER Announces Medical Policy Board, Adverse Events Reporting App

| 09 January 2012 |  By 

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) announced Friday, 6 January, that it is creating a medical policy board and a smartphone application for adverse event reporting, according to BioCentury and FDA News, respectively.

The medical policy board, first reported on Friday by BioCentury, would serve to standardize medical decision making by CDER reviewers in light of industry comments that reviewers are occasionally inconsistent when looking at similar issues. Janet Woodcock, the director of CDER, said that the board will review and establish standards, including efficacy studies in animals used to support medical countermeasures (the 'Animal Rule').

The board will be chaired by Rachel Sherman of CDER's Office of Medical Policy.

The center is also looking to develop a new adverse event (AE) reporting application that can be used on smartphone platforms, according to FDA News. The pharmacovigilance system has been under fire in recent years for being onerous and slow, with many hospitals not reporting the errors at all. The smartphone application could make reporting faster, easier and more accessible to front-line clinicians.


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