Multiple readings of the International Conference on Harmonization (ICH) guidelines for the reporting of adverse drug reactions, the current United States regulations, and the recent Food and Drug Administratin (FDA) guidance for industry may provide more questions than answers. In an attempt to provide some structure into operating under the new adverse event reporting requirements, Zeneca has prepared a series of algorithms to assist in processing suspected adverse drug reaction reports. These algorithms should be used for guidance purposes only.
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