OSE encourages companies to submit individual case safety reports electronically. FDA uses the ICH international standard for submitting electronic individual case safety reports. More than half of all reports are now received electronically; about 80 percent of 15-day reports are submitted electronically. The electronic reports cut costs for FDA and manufacturers, and the process is faster. (International Conference on Harmonisation (ICH) Guidance Documents)
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Topic: page 5 of 5 (Lesson: page 28 of 52)