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Food and Drug Administration (FDA) Proposes Changes to Investigational New Drug Applications (INDs)

The Food and Drug Administration is proposing to replace its current annual reporting requirement for investigational new drug applications (INDs) with a new requirement: the annual FDA development safety update report (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 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The proposed annual FDA DSUR regulation, if finalized, would require an annual report that is more comprehensive and informative than the IND annual report currently required under FDA regulations.

The proposed requirement is not final yet. The FDA is seeking comments. You can submit either electronic or written comments on the proposed rule by March 9, 2023.

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