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Do you know about the latest FDA proposal?
The FDA is proposing to replace its current annual reporting requirement for investigational new drug applications (INDs) with a new requirement: the annual FDA DSUR. The proposed annual FDA DSUR is intended to be consistent with the format and content of the DSUR that is supported by the ICH, which is described in the FDA's ICH guidance for industry entitled 201CE2F Development Safety Update Report 201D (E2F DSUR) (August 2011). Ongoing public consultation is open until 09-Mar-2023.
More news from competent authorities is available in iViReg. If you would like to learn more, get in touch with our team via ivireg@ivigee.com.