Experimental Drugs to Get New Reporting System With FDA Proposal

Sponsors of investigational drugs would need to comply with an internationally adopted standard for annual reporting under a new rule proposed by the FDA Thursday.

The draft rule (RIN 0910-AI37), if finalized, would replace the Food and Drug Administration’s current annual reporting system with a new requirement for a development safety update report (DSUR), which includes consistent formatting and content standards for periodic reporting on drugs under development.

The update would bring the FDA’s requirements in line with the standards for annual experimental drug reporting supported by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for ...