Drug & Device News

The U.S. Food and Drug Administration (FDA) recently issued a final rule clarifying the nature of the safety information that must be reported during clinical trials of investigational drugs and biologics. The new rule expands on the list of mandatory information, including the requirement that investigators report significant risks to study participants and divulge higher-than-expected adverse reaction rates. However, the rule also seeks to decrease over-reporting, by discouraging drug sponsors from informing the FDA of adverse events that are likely not caused by the product being tested. The new rule also revises definitions and reporting standards so that they are more consistent with those of two international organizations, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organization's Council for International Organizations of Medical Sciences. These last changes are expected to harmonize reporting of globally conducted clinical trials. For further information on the final rule, go to: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm226358.htm.