Examination of Clinical Trial Costs and Barriers for Drug Development. 4.6.4 Serious Adverse Events (SAEs) Reporting for Investigational New Drugs and Biologics (INDs) (21 CFR 312)


Legal advisors have traditionally encouraged sponsors to be nonselective in their reporting of unexpected SAEs to avoid any suspicion among regulators that they were withholding information (at least prior to March 2011, when a new drug safety reporting regulation was implemented) (Kramer, Smith, & Califf, 2012). In situations where drug sponsors are uncertain as to which events must be reported, they are inclined to err on the side of over-reporting rather than under-reporting. Possible areas of ambiguity or excess burden related to the safety reporting regulations themselves are discussed in Section 4.5.

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