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…
A Call For Alignment: US and EU Safety Reporting Requirements Read More »
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
FDA DSUR: Plans are Nothing; Planning is Everything Read More »
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
