Evaluation of Preclinical Findings for 10-Day IND Safety Reports: FDA Considerations

Abstract

When serious adverse effects are observed in preclinical safety studies being conducted after the initial investigational new drug (IND) submission, the sponsor is required to submit an IND safety report, referred to as an S-2 report. This is especially important when the drug has already entered clinical trials. Reportable adverse effects include, but are not limited to, any finding of mutagenicity, teratogenicity, or carcinogenicity. Also included would be any adverse experience not identified in the current investigator's brochure. The sponsor should report any adverse finding which appears in the open literature. Reporting an adverse experience does not constitute an admission by the sponsor that the experimental drug was, in fact, the cause. In the required follow-up report, the sponsor can present evidence to support its interpretation of the relationship between the drug and the adverse event.