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FDA’s Win-Win: More Comprehensive IND Safety Reports With Minimal Effort Due To Harmonization

 
• By Sarah Karlin-Smith

New proposed rule calls for replacing US FDA’s current annual reporting requirements for INDs with a safety update report that is consistent the format and content of the development safety update report (DSUR) supported by the International Council of Harmonisiation.

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FDA proposal would harmonize US IND reports with international community • Source: Shutterstock

The US Food and Drug Administration’s plan to require more “comprehensive and informative” annual reports on investigational new drug (IND) applications should come without a big new burden on sponsors thanks to the agency’s proposed adoption of the format and content of the development safety update report (DSUR) that is supported by the International Council for Hamonisation of Technical Requirements for Pharmaceuticals for Human Use.

FDA’s proposed rule, released on 8 December, would require sponsors to follow a reporting practice that the agency has...

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