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Regulatory News | 20 April 2018 | By Ana Mulero
The US Food and Drug Administration (FDA) on Thursday issued guidance to be implemented immediately on the submission of study datasets in developing vaccines.
The guidance, which is “designed to aid clinical and statistical reviewers in the review of vaccine applications,” including biologics license applications, according to FDA, provides details on the content of datasets agency staff expects to see.
“Any usage of domains and variables that differ from these recommendations will need to be agreed upon prior to submission of datasets,” the guidance states.
The guidance outlines five different datasets, including reactogenicity data, unsolicited adverse events, laboratory safety assessments, medically attended adverse events and deaths. The kinds of datasets FDA pinpoints in the guidance, include trial summary, demographics, vital signs, usage of adverse event, and clinical event (CE), among others.
“For clinical trials where clinical disease endpoint efficacy is an objective, efficacy data will primarily be reported in the CE domain,” the guidance adds.
Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance for Industry Technical Specifications Document