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A Call For Alignment: US and EU Safety Reporting Requirements
US and EU regulators have been strengthening requirements for aggregate safety assessments throughout clinical development. For example, Reference Safety Information in the IB should be restricted to serious adverse reactions…
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FDA DSUR: Plans are Nothing; Planning is Everything
The FDA is replacing its current annual reporting requirement for INDs with a more comprehensive and informative FDA Development Safety Update Report (FDA DSUR), which is described in FDA’s ICH…
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ASAP Process BLOG
March 1, 2023ASAP Process will be joining the Panel at the following events this year. See Our Full List of Upcoming Events UPCOMING 2023Tues, June 28th Operationalizing FDA Medical Queries…