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FDAnews Drug Daily Bulletin
Aug. 27, 2012 | Vol. 9 No. 168
Draft Guidance Suggests Updated Assessment of Suicidal Events in Trials
Drugmakers should use an updated instrument for the prospective assessment of suicidal thoughts and behaviors during clinical trials and follow new FDA advice on which trials and patients need such assessments, according to a new draft guidance. The FDA recommends proactive assessments of suicidal thought and behavior for any drug being developed for a psychiatric condition, for antiepileptic drugs and for other neurologic drugs with central nervous system activity during both inpatient and outpatient trials, including multiple-dose Phase I studies.
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