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PharPoint Research Announces Target SAE System Initiative

On September 29, 2010, FDA published a Final Rule amending the IND safety reporting requirements under 21 CFR part 312. The new requirements clearly describe circumstances in which adverse event reports should be aggregated and compared to a control group in a systematic analysis. The effective date for the Final Rule has been extended to September 28, 2011.

Attachments: Target SAE Initiative

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