FDA details new transparency plans

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For the second phase of the Food and Drug Administration transparency initiative, the agency unveiled 21 draft guidance proposals dealing with increased public disclosure of adverse events reports, drug evaluation procedures and manufacturing inspections, among several other proposals.  Draft guidance pertaining to adverse events (AE) reporting states that AE reports should be made available "in a format that is searchable and allows users to generate summary reports," including a drug's "trade name, dosage, route of administration, description of the adverse event and the health outcome."