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Common adverse event reporting form

Executive Summary

Final version of a common form for reporting adverse events associated with drugs, biologics and devices will be the topic of a June 3 FDA-sponsored conference involving representatives from the affected industries and health care professionals. A final version of the form is slated for Federal Register publication around the time of the meeting; a draft was issued in February. Health Research Group has asked FDA to delay implementation of the new form until after its effectiveness is compared to existing forms in a six-month field trial.
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