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TSRC, Tob. Sci. Res. Conf., 2016, 70, abstr. 75

The what and why of MedDRA

QURESHI S.
PSI International, Inc., Fairfax, VA, USA

The Medical Dictionary for Regulatory activities (MedDRA) is currently recommended by FDA guidance to be used for both premarket and post market adverse event reporting for Drugs and Biologics. In effect this terminology is also used in IND, NDA, and BLA submissions. If current trends are followed, this may also be mandated for the tobacco industry. The drug and biologic Industry uses the terminology in its clinical trial data and safety databases for collection of adverse events. The terminology is a dictionary of medically validated concepts of various signs, symptoms, diseases, qualitative laboratory findings, surgical procedures, some device related conditions as well as product issues. It is organized into a five level hierarchy which goes from very granular to broad. Each level will be discussed and the methodology of its application will be highlighted. The application of principles in using MedDRA on the aggregate data for analysis and trend reports will also be illustrated. The most recent addition of the Product issues terms due to Industry feedback will also be discussed with benefits of capturing product quality issues with the same terminology. The current use of MedDRA by tobacco manufacturers will be discussed as well as applicability for use in call centers and regulatory submissions for new tobacco products.